Empagliflozin and Dapagliflozin Improve Endothelial Function in Mexican Patients with Type 2 Diabetes Mellitus: A Double-Blind Clinical Trial.

AIM: To assess the acute effect of empagliflozin versus dapagliflozin administration on flow-mediated vasodilation in patients with type 2 diabetes mellitus. DESIGN: A double-blind clinical trial, at the Experimental and Clinical Therapeutics Institute, University Health Sciences Center, at the Universidad de Guadalajara, in inpatients with T2D according to the 2023 ADA criteria. METHODS: Thirty patients (15 males and 15 females), aged between 35 and 65 years, were included in this study, according to the 2023 ADA criteria. The eligible patients were randomly assigned to three groups: empagliflozin 25 mg once daily, dapagliflozin 10 mg once daily, or placebo once daily. Anthropometric parameters were taken using validated techniques. FMD was measured using a high-resolution semiautomatic ultrasound UNEX-EF 38G (UNEX Co., Ltd., Nagoya, Japan). Arterial tension was determined with the OMRON electronic digital sphygmomanometer (HEM 907 XL, Kyoto, Japan). RESULTS: The group of patients who received empagliflozin had a significantly lower baseline flow-mediated dilation (FMD) compared to the group receiving dapagliflozin (p = 0.017); at the end of this study, the empagliflozin group achieved a comparable FMD to the dapagliflozin group (p = 0.88). CONCLUSION: After the treatment period, the empagliflozin and dapagliflozin groups achieved similar FMD, suggesting a class effect.

Cinnamomum cassia on Arterial Stiffness and Endothelial Dysfunction in Type 2 Diabetes Mellitus: Outcomes of a Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Cinnamomum cassia is a medicinal plant whose use has demonstrated benefits on body weight, blood pressure, glucose, and lipids. This study aimed to evaluate the effect of C. cassia on arterial stiffness and endothelial dysfunction (ED) in patients with type 2 diabetes mellitus (T2DM). A randomized, double-blind, placebo-controlled clinical trial was carried out in 18 subjects aged 40-65 years, with a diagnosis of T2DM of one year or less since diagnosis and treated with Metformin 850 mg daily. Patients were randomly assigned to receive either C. cassia or a placebo in 1000 mg capsules, thrice a day, before each meal for 12 weeks. At baseline and after 12 weeks of intervention, brachial-ankle pulse wave velocity and Flow Mediated Dilation were measured, as well as body weight, body mass index (BMI), blood pressure (BP), fasting glucose (FG), glycated hemoglobin A1c (HbA1c), total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, and very low density lipoprotein cholesterol, respectively, triglycerides, creatinine, and transaminases. The Mann-Whitney U test for differences between groups and the Wilcoxon signed-rank test for intragroup differences were used, and a P ≤ .05 was considered statistically significant. After C. cassia administration, statistically significant reductions in body weight (81.4 ± 10.4 kg vs. 79.9 ± 9.0 kg, P = .037), BMI (30.6 ± 4.2 kg/m2 vs. 30.1 ± 4.2 kg/m2, P = .018), and HbA1c (53 ± 5.4 mmol/mol vs. 45 ± 2.1 mmol/mol, P = .036) were observed. No changes statistically significant on arterial stiffness, ED, FG, BP, and lipids were observed. C. cassia administration decreases body weight, BMI, and HbA1c without statistically significant changes on arterial stiffness, ED, FG, BP, and lipids. CTR Number: NCT04259606.

Association of Netrin 1 with hsCRP in Subjects with Obesity and Recent Diagnosis of Type 2 Diabetes.

Netrin 1 (Ntn1) is a cell migration protein with an anti-inflammatory effect, which may play a key role in the pathological development of type 2 diabetes (T2D). In this study, we evaluate the relationships between the serum concentrations of Ntn1, glucose, and high-sensitivity C-reactive Protein (hsCRP). We carried out a cross-sectional study including 90 individuals divided into three groups (n = 30): healthy subjects, individuals with obesity without glucose alterations, and individuals with newly diagnosed T2D. Serum concentrations of Ntn1 and hs-CRP were determined by enzyme-linked immunosorbent assay (ELISA). The serum concentration of Ntn1 was higher in individuals with newly diagnosed T2D (0.33 ± 0.22 ng/mL), in comparison to healthy subjects and individuals with obesity (0.13 ± 0.06 and 0.15 ± 0.07 ng/mL, respectively). In addition, we observed a positive association between the levels of Ntn1 and hsCRP (rho = 0.443; p < 0.001) as well as with serum glucose (rho = −0.110; p = 0.05). The serum concentration of Ntn1 was higher in individuals with T2D, in comparison with the other groups in this study, and presented a positive correlation with hsCRP. Therefore, Ntn1 can be considered a promising risk biomarker and a potential therapeutic target for T2D.

Green Tea Extract Increases Soluble RAGE and Improves Renal Function in Patients with Diabetic Nephropathy.

One of the proposed mechanisms for the development of diabetic nephropathy (DN) is the increase of end products of advanced glycosylation (AGEs), which bind to its receptor (RAGE), favoring nephron cellular damage. An isoform of this receptor is soluble RAGE (sRAGE), which can antagonize AGE-altered intracellular signaling. It has known that green tea extract (GTE) increases the expression of sRAGE, but it is unknown whether this could improve kidney function. The objective of this study was to evaluate the effect of the administration of GTE on the concentrations of sRAGE, renal function, and metabolic profile in patients with type 2 diabetes mellitus (T2DM) and DN. A randomized, double-blinded, placebo-controlled clinical trial was carried out in 39 patients who received GTE (400 mg every 12 h) or placebo for 3 months. sRAGE levels, renal function, and metabolic parameters were determined before and after the intervention. In the GTE group, there were statistically significant increase on sRAGE (320.55 ± 157.63 pg/mL vs. 357.59 ± 144.99 pg/mL; P = .04) and glomerular filtration rate (GFR; 66.44 ± 15.17 mL/min/1.73 m2 vs. 71.70 ± 19.33 mL/min/1.73 m2; P = .04), and a statistically significant decrease in fasting serum glucose (7.62 ± 3.00 mmol/L vs. 5.86 ± 1.36 mmol/L; P ≤ .01) and triacylglycerols (1.91 ± 0.76 mmol/L vs. 1.58 ± 0.69; P = .02). Administration of GTE increases the serum concentration of sRAGE and the GFR and decreases the concentration of fasting serum glucose and triacylglycerols. The study was registered in ClinicalTrials.gov with the identifier NCT03622762.

Administration of Herbarium Mixture (Guazuma ulmifolia/Tecoma stans) on Metabolic Profile in Type 2 Diabetes Mellitus Patients: A Randomized, Double-Blind, Placebo-Controlled Trial.

The use of herbarium mixture has been empirical, and the properties are not yet known. The aim of this study was to evaluate the effect of oral administration of herbarium mixture (Guazuma ulmifolia [G. ulmifolia]/Tecoma stans [T. stans]) on metabolic profile in patients with type 2 diabetes mellitus (T2DM). A randomized, double-blind, placebo-controlled, clinical trial was carried out in 40 patients with T2DM. They were between 40 and 65 years of age, with body mass index (BMI) between 25.0 and 34.9 kg/m2 and HbA1c >7.0%. BMI, waist circumference, fasting glucose, HbA1c, lipids, kidney, and liver function were measured. The patients were randomly assigned to receive the herbarium mixture (G. ulmifolia/T. stans) 400 mg before each meal, or placebo for 90 days. Herbarium mixture group showed decreased waist circumference (99 ± 14 vs. 98 ± 15 cm; P = .019), fasting glucose (12.0 ± 5.7 vs. 10.3 ± 5.1 mM; P = .019), and HbA1c (9.9% ± 2.7% vs. 8.9% ± 2.5%, P = .002). In conclusion, the administration of herbarium mixture (G. ulmifolia/T. stans) improved the glycemic profile in patients with T2DM. ClinicalTrial registration: NCT03313856 ClinicalTrials.gov.

Effect of green tea extract on arterial stiffness, lipid profile and sRAGE in patients with type 2 diabetes mellitus: a randomised, double-blind, placebo-controlled trial.

Type 2 diabetes mellitus (T2DM) is associated with premature atherosclerosis and arterial stiffening due to the accumulation of advanced glycation end-products in vessel walls. Green tea polyphenols are considered cardio-protective substances. In this randomised double-blind placebo-controlled trial (NCT02627898), we evaluated the effect of Green tea extract on arterial stiffness parameters, lipids, body composition and sRAGE levels. Twenty normotensive patients with T2DM treated with the standard therapy and statins, mean age 53.2 ± 9.4 years and mean BMI 30.1 ± 4.5 kg/m2, were randomised to receive a daily dose of 400 mg of green tea extract (polyphenols ≥90%, EGCG ≥45%) or placebo for 12 weeks. Compared to placebo, administration of green tea extract decreased central augmentation index (-3.05 ± 10.8% vs. 6.7 ± 0.1%, p = .04). These findings suggest that green tea extract could be used as an adjunct to the standard therapy to improve arterial stiffness in T2DM.

Efficacy and safety of the combination of isosorbide dinitrate spray and chitosan gel for the treatment of diabetic foot ulcers: A double-blind, randomized, clinical trial.

AIM: To evaluate whether a combination of isosorbide dinitrate spray and chitosan gel (10%) topically applied can have additive benefits for management of diabetic foot ulcers. METHODS: In a randomized, placebo-controlled, double-blinded clinical trial, 68 patients were divided into four groups: Group 1: treated with chitosan gel; Group 2: isosorbide dinitrate spray; Group 3: combination of isosorbide dinitrate spray and chitosan gel; Group 4: placebo. RESULTS: Histological analyses showed a significant regeneration in all groups ( p < 0.001). On the final assessment of the ulcer, using the combination was found a wound closure percentage of 71 ± 30, 70 ± 27 using isosorbide dinitrate, 58 ± 30 with chitosan and 50 ± 16 with placebo. The number of patients who achieved complete ulcer closure was six using the combination, four with isosorbide dinitrate, three with chitosan and one with placebo. The progression in the healing process of the ulcer showed marked inmunohistochemical differences of Von Willebrand Factor, desmin, vascular endothelial growth factor-A and α-smooth muscle actin in all groups ( p < 0.001), but without notable differences between them. CONCLUSION: The combination was better than placebo to reduce the dimensions of the ulcer, accelerate healing and increase the number of patients who achieved complete closure of the ulcer, but the combination was not better than chitosan or isosorbide dinitrate used separately.

Effect of Alpha-Lipoic Acid on Clinical and Neurophysiologic Recovery of Carpal Tunnel Syndrome: A Double-Blind, Randomized Clinical Trial.

The objective of our study was to examine the effect of alpha-lipoic acid (ALA) on clinical and neurophysiologic outcomes after surgery for idiopathic carpal tunnel syndrome (CTS). We conducted a randomized, double-blind, placebo-controlled clinical trial in 20 adults diagnosed with idiopathic CTS after clinical and neurophysiologic assessment. Eligible participants took 600 mg ALA or placebo per day for 1 month before surgery, and for 2 months afterward. Further clinical and neurophysiologic assessments were undertaken immediately before surgical decompression, and at 12 weeks postoperatively with additional clinical assessments at the 4th and 8th week after surgery. Clinical outcome measures were taken by Boston Questionnaire score, the presence or absence of Tinel's sign, and Phalen's test findings. Median nerve conduction studies were also undertaken and interpreted according to Dumitru's reference values. Nineteen patients completed the study; one member of the placebo group was lost during follow-up. There were significant improvements in clinical and neurophysiologic variables in the ALA treatment group, present even before surgery. Boston Questionnaire scores had improved significantly in both groups. In the ALA group, none of the participants had positive Phalen's or Tinel's signs at 12 weeks, and motor and sensory fiber latency and amplitude had significantly improved; in the placebo group, only the sensory distal latency had improved significantly. In conclusion, ALA administered 1 month before open decompression and for 2 months afterward improves the clinical and neurophysiologic outcomes after surgery.

Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension / Seguridad y eficacia de fimasartán en pacientes mexicanos con hipertensión esencial de grados 1-2

Abstract: Objective: To evaluate efficacy and safety of 60 mg and 120 mg Fimasartan (FMS) alone or combined with 12.5 mg hydrochlorothiazide (HCTZ) in a Mexican population. Methods: A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60 mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90 mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90 mmHg were randomised to either 120 mg FMS or 60 mg FMS + 12.5 mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90 mmHg received 120 mg FMS + 12.5 mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study. Results: FMS 60 mg (n = 272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3 ± 8.9 (p<.0001) and 16.0 ± 14.1 (p<.0001) mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120 mg, FMS 60 mg + HCTZ 12.5 mg, or FMS 120 mg + HCTZ 12.5 mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP < 90 mmHg and an SBP<140 mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%). Conclusion: Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.

Resumen: Objetivo: Evaluar la eficacia y la seguridad de 60 y 120 mg de fimasartán (FMS) solo o combinado con 12.5 mg de hidroclorotiazida (HCTZ) en población mexicana. Métodos: Estudio abierto, de 24 semanas, con tratamiento escalado hasta el objetivo terapéutico en sujetos hipertensos grados 1-2. Tratamiento inicial: FMS 60 mg una vez al día; en la semana 8, los sujetos con presión arterial diastólica (PAD) <90 mmHg mantuvieron su tratamiento inicial durante el estudio, mientras que los sujetos con PAD ≥90 mmHg fueron aleatorizados a 120 mg de FMS o a 60 mg de FMS + 12.5 mg de HCTZ. En la semana 12, los sujetos aleatorizados con PAD ≥90 mmHg recibieron 120 mg de FMS + 12.5 mg de HCTZ; quienes alcanzaron el objetivo terapéutico mantuvieron su tratamiento asignado hasta finalizar el estudio. Resultados: FMS 60 mg (n = 272) disminuyó la PAD y la presión arterial sistólica (PAS) en 11.3 ± 8.9 (p < 0.0001) y 16.0 ± 14.1 (p < 0.0001) mmHg, respectivamente, con logro del objetivo de tratamiento en el 75.4% de los sujetos. Los sujetos asignados a 120 mg de FMS, a 60 mg de FMS + 12.5 mg de HCTZ 12.5 y a 120 mg de FMS + 12.5 mg de HCTZ mostraron reducciones significativas de PAD y PAS; al final del estudio, 237/272 sujetos (87.1%) lograron PAD <90 y PAS <140 mmHg. Las reacciones adversas más frecuentemente reportadas fueron: cefalea (3.7%), boca seca (1.1%), incremento de enzimas hepáticas (1.1%) y mareo (0.7%). Conclusión: FMS es seguro y eficaz en sujetos mexicanos con hipertensión esencial de grados 1-2.

Serum levels of undercarboxylated osteocalcin are related to cardiovascular risk factors in patients with type 2 diabetes mellitus and healthy subjects.

AIM: To determine a potential relationship between serum undercarboxylated (ucOC) concentration and cardiovascular risk factors in type 2 diabetes (T2D) patients and healthy subjects (HS). METHODS: A cross-sectional study was conducted on 140 subjects classified into two groups, 70 with T2D and 70 HS. Medical history and physical examination with anthropometric measurements were obtained from all subjects. Body fat percentage was determined by bioelectrical impendency analysis. Serum ucOC concentration was determined by enzyme immunoassay, while serum levels of insulin and hsCRP were obtained using high sensitivity enzyme-linked immunosorbent assay. Insulin resistance was determined using the homeostasis model assessment-IR. Lipid profile [triglycerides, total cholesterol (TC), high-density lipoproteins (HDL-c), low density lipoproteins (LDL-c), very low-density lipoproteins] was determined by spectrophotometry and standard formulas when applicable. RESULTS: The T2D patient group showed significantly higher values of waist circumference, waist-to-hip ratio, systolic blood pressure (SBP), diastolic blood pressure (DBP), current smoking, and alcohol use when compared to the HS group (P < 0.05). We observed a significantly lower serum ucOC concentration in T2D than in HS (1.5 ± 1.4 vs 2.3 ± 1.8, P < 0.05). In the whole study population, ucOC concentration was inversely correlated with body mass index (BMI) (r = -0.236, P < 0.05), fasting plasma glucose (r = -0.283, P < 0.01) and HDL-c (r = -0.255, P < 0.05); and positively correlated with LDL-c/HDL-c ratio (r = 0.306, P < 0.05) and TC/HDL-c ratio (r = 0.284, P < 0.05). In the T2D group, serum ucOC concentration was inversely correlated with BMI (r = -0.310, P < 0.05) and body-fat percentage (r = -0.311, P < 0.05), and positively correlated with DBP (r = 0.450, P < 0.01). In HS group a positive correlation between serum levels of ucOC and SBP (r = 0.277, P < 0.05) was observed. CONCLUSION: Serum ucOC is a potential marker for cardiovascular risk in Mexicans because it is related to adiposity parameters, blood pressure and lipid profile.

Safety and efficacy of fimasartan in Mexican patients with grade 1-2 essential hypertension.

OBJECTIVE: To evaluate efficacy and safety of 60mg and 120mg Fimasartan (FMS) alone or combined with 12.5mg hydrochlorothiazide (HCTZ) in a Mexican population. METHODS: A six month, treat-to-target, open study was conducted on subjects with grade 1-2 hypertension. The subjects were initially treated with 60mg FMS once daily. In week 8, those with Diastolic Blood Pressure (DBP) <90mmHg continued on the same FMS dose during the rest of the study, while those with DBP ≥90mmHg were randomised to either 120mg FMS or 60mg FMS + 12.5mg HCTZ once daily. In week 12, randomised subjects with DBP ≥90mmHg received 120mg FMS+12.5mg HCTZ, while those achieving target continued with their assigned treatment until the end of the study. RESULTS: FMS 60mg (n=272) decreased both DBP and Systolic Blood Pressure (SBP) by 11.3±8.9 (p<.0001) and 16.0±14.1 (p<.0001)mmHg, respectively, with 75.4% of subjects reaching the treatment target. Subjects assigned to FMS 120mg, FMS 60mg+HCTZ 12.5mg, or FMS 120mg+HCTZ 12.5mg once daily, showed significant reductions in DBP and SBP with their assigned treatment. At the end of the study, 237/272 subjects (87.1%) achieved a DBP<90mmHg and an SBP<140mmHg. The most frequently reported adverse reactions included headache (3.7%), dry mouth (1.1%), transient liver enzyme increase (1.1%), and dizziness (0.7%). CONCLUSION: Fimasartan is safe and effective in Mexican subjects with grade 1-2 essential hypertension.

Efecto de la ingesta de tortilla con inulina sobre perfil metabólico en pacientes con dislipidemia e IMC > 25 / Effect of consumption of tortilla with inulin on metabolic profile in patients with dyslipidemia and BMI > 25

Introducción: La inulina es un prebiótico usado como tratamiento alternativo o preventivo de enfermedades como la obesidad, la hiperglucemia o diabetes mellitus y la dislipidemia, una estrategia para su consumo es ofrecerla en un alimento de consumo diario como lo es la tortilla. Objetivo: Evaluar la ingesta de tortillas de maíz enriquecidas con inulina sobre perfil metabólico en pacientes con dislipidemia e IMC >25. Métodos: Ensayo clínico de 1 brazo, se incluyeron 22 pacientes con sobrepeso u obesidad (IMC ≥25) y dislipidemia; que reportaron ingesta de al menos 5 tortillas diarias, las cuales se cambiaron por tortillas enriquecidas con 1 gr de inulina por 90 días. Resultados: Se mostraron cambios en la glucosa sérica, al disminuir 10% en comparación con cifras basales (p>0.016). Se mostró tendencia clínica a disminución de insulina y colesterol total, resto sin cambios significativos. Discusión: Se encontraron diferencias clínicas con reducción de cifras de colesterol total de 40 mg en promedio, aunque no resultó estadísticamente significativo, lo que contrasta con estudios anteriores con ingesta de inulina en los cuales se reporta disminución estadísticamente significativa de los lípidos séricos como LDL y/o colesterol total, cabe señalar que la inulina utilizada fue de Agave Tequilana Weber, que presenta cambios en su estructura molecular con otras inulinas, además que en el presente estudio el consumo promedio fue de 4.32 g/día contra 7.4 g y hasta 30 g/día en otros estudios. El efecto hipoglucemiante resultante fue estadísticamente significativo para pacientes sin hiperglucemia ni diabetes, el probable mecanismo de acción es por aumento del péptido similar al glucagón tipo 1, por otra parte no hubo cambios en el peso corporal aunque la inulina suele hacer cambios en la microbiota intestinal que suele generar disminución del sobrepeso o la obesidad. Conclusiónes: El consumo diario de tortillas de maíz adicionadas de 1 g de inulina disminuye la glucemia y muestra una tendencia no estadística a disminuir los niveles de insulina sérica y colesterol total (AU)

Introduction: Inulin is a prebiotic that could help as an alternative or preventive treatment of diseases such as obesity, hyperglycemia or diabetes mellitus and dyslipidemia, a strategy for its consumption is to offer it in a food of daily consumption as is the tortilla. Objective: To evaluate the intake of corn tortillas enriched with inulin on a metabolic profile in patients with dyslipidemia and BMI> 25. Methods: One arm clinical trial included 22 patients with overweight or obesity (BMI ≥25) and dyslipidemia; That they present an ingestion of at least 5 tortillas daily, which were changed by tortillas enriched with 1 gr of inulin for 90 days. Results: Changes in serum glucose were shown, decreasing 10% compared to baseline (p> 0.016). Clinical tendency to decrease insulin and total cholesterol, rest without significant changes. Discussion: Clinical differences were found with a reduction in total cholesterol levels of 40 mg on average, but not statistically significant, which contrasts with previous inulin intake studies in which a statistically significant decrease in serum lipids such as LDL and / or Total cholesterol, it should be noted that the inulin used was Agave Tequilana Weber, which presents changes in its molecular structure versus other inulins, and in the present study the average consumption was 4.32 g / day against 7.4 g and up to 30 g / day in other studies. The resulting hypoglycaemic effect was statistically significant for patients without hyperglycemia or diabetes, the mechanism of action is by increased glucagon-like peptide type 1, on the other hand there were no changes in body weight although inulin usually makes changes in the intestinal microbiota, which usually leads to a decrease in overweight or obesity. Conclusion: The daily consumption of corn tortillas added with 1 g of inulin lowers glycemia and shows a non-statistical tendency to decrease serum insulin and total cholesterol levels (AU)

Effectiveness of degradable and non-degradable implants to close large septal perforations in an experimental model.

Background Reparation of large nasal septum perforations continues to be challenging. Bipedicled mucoperichondrial and inter-positional grafts currently show the most promising results. New implants have emerged to be used as a support membrane to carry on the mucosal cells, taking advantage of the innate proliferative properties of the mucosal tissue. Objective To compare the effectiveness of two kinds of material; non-absorbable dimethylsiloxane (silicone elastomers) and absorbable porcine small intestinal submucosa (Surgisis), both used as an inter-positional graft without neighbouring flaps to close nasal septal perforations in an experimental model. Methods Fifteen dogs were divided into three groups. One group received Surgisis, the other sheets of dimethylsiloxane and the last group a sham group. The dogs were followed for 6 weeks. Results The initial perforation of the nasal septum showed complete mucosal closure in the dimethylsiloxane group. The Surgisis group, on the other hand, had a smaller reduction than that at the beginning (final mean area = 23.0 ± 5.4 mm(2) (p < 0.05); however, complete closure was not achieved. Sham animals showed an inconstant and slight reduction in dimension from 100 mm(2) to 70 ± 16 mm(2) of mucosa and cartilage, but closure was not achieved. A significantly higher number of capillaries were observed in the Surgisis group compared to the dimethylsiloxane group (p < 0.05) without differences in inflammation, fibrosis, or necrosis. Conclusions The non-absorbable implant; dimethylsiloxane facilitates a better closure of the nasal septum.

The effect of ubiquinone in diabetic polyneuropathy: a randomized double-blind placebo-controlled study.

INTRODUCTION: Diabetic polyneuropathy aetiology is based on oxidative stress generation due to production of reactive oxygen species. Ubiquinone is reduced to ubiquinol and redistributed into lipoproteins, possibly to protect them from oxidation. AIMS: To evaluate the impact of oral ubiquinone in diabetic polyneuropathy, and the role of lipid peroxidation (LPO) and nerve growth factor (NGF-ß). METHODS: We conducted a double-blind, placebo-controlled clinical trial, patients were randomized to ubiquinone (400 mg) or placebo daily for 12 weeks. Main outcomes were clinical scores, nerve conduction studies, LPO, NGF-ß and safety. RESULTS: Twenty four patients on experimental group and twenty five on control group met the inclusion criteria (mean age 56 years, 22% male and 78% female, mean evolution of type 2 diabetes mellitus 10.7 years). Significant improvement on experimental vs control group was found in neuropathy symptoms score (from 2.5 ± 0.7 to 1 ± 0.8, p<0.001), neuropathy impairment score (5.5 ± 4 to 3.1 ± 2.6, p<0.001), sural sensory nerve amplitude (13.0 ± 6.1 to 15.8 ± 5.1 µV, p=0.049), peroneal motor nerve conduction velocity (39.7 ± 5.0 to 47.8 ± 4.9 m/s, p=0.047), and ulnar motor nerve conduction velocity (48.8 ± 6.8 to 54.5 ± 6.1m/s, p=0.046). There was a significant reduction of LPO in subjects treated with ubiquinone vs placebo (16.7 ± 8.6 and 23.2 ± 15.8 nmol/mL, respectively) with p<0.05, and NGF-ß did not change (control 66.5 ± 26.7 vs. experimental 66.8 ± 28.4 pg/mL, p=0.856). No drug-related adverse reactions were reported. CONCLUSIONS: Twelve weeks treatment with ubiquinone improves clinical outcomes and nerve conduction parameters of diabetic polyneuropathy; furthermore, it reduces oxidative stress without significant adverse events.

Impacto de la hiperinsulinemia sobre la función del ventrículo izquierdo en sujetos hipertensos / Differential impact of hyperinsulinemia on left ventricular function in hypertense subjects

Introducción: La hiperinsulinemia asociada a hipertensión arterial activa el proceso inflamatorio/reparador y deteriora la función ventricular. Objetivo: Determinar los efectos de la hiperinsulinemia sobre la masa la ventricular y función diastólica del ventrículo izquierdo (VI) en hombres y mujeres no diabéticos con hipertensión. Método: 52 pacientes con curva de tolerancia a la glucosa normal fueron estratificados según la relación glucosa/insulina (rG/I): Grupo 1, hiperinsulinémico (rG/I < 1.6); Grupo 2, normoinsulinémico (rG/I > 1.6). Se realizó historia clínica, análisis de laboratorio, ECG y ecografía Doppler cardíaca. Resultados: En condición basal no hubo diferencias entre los grupos en cuanto a edad, valores de glucemia y presión arterial, pero sí en los de insulina (32.5 vs. 8.78 mU/ml), masa ventricular (131.6 vs. 92.7 g/m2), fracción de eyección del VI (73.5 vs. 69.3%), índice de masa corporal (31.2 vs. 29 kg/m2), relación E/A mitral (0.92 vs. 1.35), tiempo de relajación isovolumétrica del VI (126.3 61 ms) y tiempo de hemipresión transmitral (T1/ 2; 206 vs. 244.4 ms). En las mujeres hiperinsulinémicas se incrementaron más los niveles de insulina a 60 que en los hombres (12.5 vs. 6.7 veces), rG/I de 0.54 vs. 0.99, masa ventricular (61.4 vs. 30.7%), disfunción diastólica del VI (E/A 0.87 vs. 0.93 y T1/2; 191.7 vs. 220.3 ms). Conclusión: La hiperinsulinemia incrementa la masa ventricular y deteriora la función diastólica del VI en pacientes hipertensos no diabéticos, con mayor gravedad en las mujeres.(AU)

Impacto de la hiperinsulinemia sobre la función del ventrículo izquierdo en sujetos hipertensos / Differential impact of hyperinsulinemia on left ventricular function in hypertense subjects

Introducción: La hiperinsulinemia asociada a hipertensión arterial activa el proceso inflamatorio/reparador y deteriora la función ventricular. Objetivo: Determinar los efectos de la hiperinsulinemia sobre la masa la ventricular y función diastólica del ventrículo izquierdo (VI) en hombres y mujeres no diabéticos con hipertensión. Método: 52 pacientes con curva de tolerancia a la glucosa normal fueron estratificados según la relación glucosa/insulina (rG/I): Grupo 1, hiperinsulinémico (rG/I < 1.6); Grupo 2, normoinsulinémico (rG/I > 1.6). Se realizó historia clínica, análisis de laboratorio, ECG y ecografía Doppler cardíaca. Resultados: En condición basal no hubo diferencias entre los grupos en cuanto a edad, valores de glucemia y presión arterial, pero sí en los de insulina (32.5 vs. 8.78 mU/ml), masa ventricular (131.6 vs. 92.7 g/m2), fracción de eyección del VI (73.5 vs. 69.3%), índice de masa corporal (31.2 vs. 29 kg/m2), relación E/A mitral (0.92 vs. 1.35), tiempo de relajación isovolumétrica del VI (126.3 61 ms) y tiempo de hemipresión transmitral (T1/ 2; 206 vs. 244.4 ms). En las mujeres hiperinsulinémicas se incrementaron más los niveles de insulina a 60' que en los hombres (12.5 vs. 6.7 veces), rG/I de 0.54 vs. 0.99, masa ventricular (61.4 vs. 30.7%), disfunción diastólica del VI (E/A 0.87 vs. 0.93 y T1/2; 191.7 vs. 220.3 ms). Conclusión: La hiperinsulinemia incrementa la masa ventricular y deteriora la función diastólica del VI en pacientes hipertensos no diabéticos, con mayor gravedad en las mujeres.

[Association of hyperinsulinemia with left ventricular hypertrophy and diastolic dysfunction in patients with hypertension]. / Relación entre hiperinsulinemia, disfunción diastólica e hipertrofia del ventrículo izquierdo en pacientes con hipertensión arterial sistémica.

BACKGROUND: Hypertension is the main independent cardiovascular risk factor. However, there are additional factors that induce organic damage. AIM: To assess the association between hyperinsulinemia, ventricular hypertrophy and left ventricular diastolic function. PATIENTS AND METHODS: Seventy-four patients aged 30 to 65 years, with mild or moderate systemic hypertension, with overweight or mild obesity and normal glucose tolerance curve (GTC), were studied. Serum insulin was measured during GTC. The maximum levels of insulin and glucose were observed 60 minutes after the oral glucose load and they were expressed as rG/1. Patients were stratified in three groups according to their glucose and insulin fasting levels (I0) and post-glucose challenge levels (rG/I): Group 1 (normoinsulinemic patients) I0 <17 mU/mL and rG/I >2 (2.45+0.4). Group 2 (post-prandial hyperinsulinemic patients) I0 <17 mU/mL and rG/I <2> 1 (1.34+0.3). Group 3 (persistently hyperinsulinemic patients) I0 >17 mU/mL and <1 (0.7+0.3). Left ventricular mass and its diastolic function were measured by Doppler echocardiography. RESULTS: No differences in blood pressure or age were observed between groups. There was a negative correlation between ventricular mass and rG/1 (r =-0.282, p =0.015). Left ventricular diastolic dysfunction was significantly more deteriorated in group 3, as compared with group 1 (p <0.001 ANOVA). There was a significant correlation between g/GI and diastolic dysfunction (r =0.232 p =0.047). CONCLUSIONS: Fasting, post challenge hyperinsulinemia and a rG/I <1 are associated with higher ventricular mass and left ventricular diastolic dysfunction, independent of blood pressure and age.

Relación entre hiperinsulinemia, disfunción diastólica e hipertrofia del ventrículo izquierdo en pacientes con hipertensión arterial sistémica / Association of hyperinsulinemia with left ventricular hypertrophy and diastolic dysfunction in patients with hypertension

Background: Hypertension is the main independent cardiovascular risk factor. However, there are additional factors that induce organic damage. Aim: To assess the association between hyperinsulinemia, ventricular hypertrophy and left ventricular diastolic function. Patients and Methods: Seventy-four patients aged 30 to 65 years, with mild or moderate systemic hypertension, with overweight or mild obesity and normal glucose tolerance curve (GTC), were studied. Serum insulin was measured during GTC. The maximum levels of insulin and glucose were observed 60 minutes after the oral glucose load and they were expressed as rG/1. Patients were stratified in three groups according to their glucose and insulin fasting levels (I0) and post-glucose challenge levels (rG/I): Group 1 (normoinsulinemic patients) I0 <17 mU/mL and rG/I >2 (2.45+0.4). Group 2 (post-prandial hyperinsulinemic patients) I0 <17 mU/mL and rG/I <2> 1 (1.34+0.3). Group 3 (persistently hyperinsulinemic patients) I0 >17 mU/mL and <1 (0.7+0.3). Left ventricular mass and its diastolic function were measured by Doppler echocardiography. Results: No differences in blood pressure or age were observed between groups. There was a negative correlation between ventricular mass and rG/1 (r =-0.282, p =0.015). Left ventricular diastolic dysfunction was significantly more deteriorated in group 3, as compared with group 1 (p <0.001 ANOVA). There was a significant correlation between g/GI and diastolic dysfunction (r =0.232 p =0.047). Conclusions: Fasting, post challenge hyperinsulinemia and a rG/I <1 are associated with higher ventricular mass and left ventricular diastolic dysfunction, independent of blood pressure and age.

Effect of tequila on homocysteine, insulin secretion, insulin sensitivity, and metabolic profile in healthy men.

AIM: The purpose of this study is to identify the effect of a low dose of tequila on homocysteine, insulin secretion, insulin sensitivity, and metabolic profile in healthy young men. METHODS: An open clinical trial was carried out in eight healthy nonobese, young male volunteers. The study was divided in two phases. The first one evaluated metabolic changes, including insulin secretion and sensitivity due to acute administration of 30 ml of straight tequila. The second phase of the study evaluated metabolic effects due to the daily administration of 30 ml of tequila during 30 days. RESULTS: There were no significant metabolic changes after the single oral administration of 30 ml of straight tequila. After the administration of tequila during 30 days, a significant increase in homocysteine levels and a tendency to increase the glucose concentration and to decrease the insulin sensitivity were found. CONCLUSION: Detrimental metabolic changes were observed with the daily administration of 30 ml of tequila during 30 days.

Effect of celecoxib, a cyclooxygenase-2-specific inhibitor, on insulin sensitivity, C-reactive protein, homocysteine, and metabolic profile in overweight or obese subjects.

BACKGROUND: The aim of this study was to assess the effect of celecoxib, a cyclooxygenase- 2-specific inhibitor, on insulin sensitivity, C-reactive protein, homocysteine, and metabolic profile in overweight or obese subjects. METHODS: A randomized, double-blind, placebo-controlled clinical trial was carried out on 12 overweight or obese (body mass index, 25-35 kg/m(2)) male volunteers. Six subjects received celecoxib 200 mg orally in the morning for a period of 4 weeks. Six other individuals took a placebo for the same period of time, as the control group. Before and after the 4-week study period, insulin sensitivity, C-reactive protein, homocysteine levels, and metabolic profile were estimated. To assess insulin sensitivity, the euglycemic-hyperinsulinemic clamp technique was performed. RESULTS: There were no significant differences in the basal measurements between both groups. C-reactive protein, homocysteine, and metabolic profile were not modified by the pharmacologic intervention with placebo or celecoxib. The insulin sensitivity after celecoxib was significantly higher compared with the basal estimation (3.8 +/- 1.2 vs. 2.8 +/- 1.2 mg/kg/min; p = 0.028). The placebo did not modify the insulin sensitivity. CONCLUSIONS: The specific inhibition of the cyclooxygenase-2 by celecoxib increased the insulin sensitivity in overweight or obese subjects, without modification in C-reactive protein, homocysteine levels, and metabolic profile.