Comparison of the use of blood pressure telemonitoring versus standard medical care in the achievement of short-term therapeutic goals in blood pressure in patients with uncontrolled hypertension: An open-label clinical trial.

Background: In Mexico less than half of the treated hypertensive patients reach blood pressure (BP) targets. Most hypertensive individuals rely on the standard medical care (SMC) to achieve the BP control goals; however, the efficacy of BP telemonitoring (BPT) to achieve BP targets has been poorly studied. Aim: To compare the efficacy of BPT versus SMC to achieve BP goals in patients with uncontrolled hypertension. Methods: A two-arm, open-label clinical trial was conducted in patients ≥18 years with uncontrolled hypertension. The participants were randomized to 2 arms (BPT vs SMC) and followed for 12 weeks. For the statistical analysis, the chi-squared test and covariance were used. Results: One hundred and seventy-eight participants were included, BPT (n = 94) and SMC (n = 84), after 12 weeks of follow up, we observed a baseline-adjusted reduction in systolic BP with both BPT (-13.5 [1.3] mmHg) and the SMC (-5.9 [1.4] mmHg; p < 0.001) but a greater decrease with BPT (p < 0.001). Likewise, we found a baseline-adjusted reduction of diastolic BP with BPT (-6.9 [0.9] mmHg) and SMC (-2.7 [0.9] mmHg) (p = 0.007) with a more significant percentage change from baseline with BPT (-6.8% [1.0] vs 2.5% [1.1]; p = 0.007). In the BPT arm, a larger proportion of patients achieved the BP target versus SMC (30.5% vs 12.8%; p = 0.005). Conclusion: BPT showed a greater proportion of patients achieving office BP control goals (<140/90 mmHg), compared to standard medical care.

Effect of supplementation with vitamins D3 and K2 on undercarboxylated osteocalcin and insulin serum levels in patients with type 2 diabetes mellitus: a randomized, double-blind, clinical trial.

BACKGROUND: Patients with type 2 diabetes mellitus (T2DM) are characterized by chronic hyperglycemia as a consequence of decreased insulin sensitivity, which contributes to bone demineralization and could also be related to changes in serum levels of osteocalcin and insulin, particularly when coupled with a deficiency in the daily consumption of vitamins D3 and K2. The objective of this study was to evaluate the effect of vitamin D3 and vitamin K2 supplements alone or in combination on osteocalcin levels and metabolic parameters in patients with T2DM. METHODS: A double-blind, randomized clinical trial was carried out in 40 patients aged between 30 and 70 years old for 3 months. Clinical and laboratory assessment was carried out at the beginning and at the end of the treatment. The patients were divided into three groups: (a) 1000 IU vitamin D3 + a calcinated magnesium placebo (n = 16), (b) 100 µg of Vitamin K2 + a calcinated magnesium placebo (n = 12), and (c) 1000 IU vitamin D3 + 100 µg vitamin K2 (n = 12). RESULTS: After treatment in the total studied population, a significant decrease in glycemia (p = 0.001), HOMA-IR (Homeostatic model assessment-insulin resistance) (p = 0.040), percentage of pancreatic beta cells (p < 0.001), uOC/cOC index and diastolic blood pressure (p = 0.030) were observed; in vitamin D3 group, differences in serum undercarboxylated osteocalcin (p = 0.026), undercarboxylated to carboxylated osteocalcin index (uOC/cOC) (p = 0.039) glucose (p < 0.001) and  % of functional pancreatic beta cells (p < 0.001) were demonstrated. In vitamin K2 group a significant decrease in glycemia (p = 0.002), HOMA-IR (p = 0.041), percentage of pancreatic beta cells (p = 0.002), and in cOC (p = 0.041) were observed, conversely cOC concentration was found high. Finally, in the vitamins D3 + K2 a significant decrease in glycemia (p = 0.002), percentage of pancreatic beta cells (p = 0.004), and in the uOC/cOC index (p = 0.023) were observed. CONCLUSION: Individual or combined supplementation with vitamins D3 and K2 significantly decreases the glucose levels and  % of functional pancreatic beta cells, while D3 and D3 + K2 treatments also induced a reduction in the uOC/cOC index. Only in the group with vitamin D3 supplementation, it was observed a reduction in undercarboxylated osteocalcin while vitamin K2 increased the carboxylated osteocalcin levels.Trial registration NCT04041492.

Efficacy of L-arginine for preventing preeclampsia in high-risk pregnancies: A double-blind, randomized, clinical trial.

OBJECTIVE: This study aimed to estimate the effectiveness of L-arginine for preventing preeclampsia in high-risk pregnancy. METHODS: We performed a randomized, double-blind, placebo-controlled, clinical trial in patients with high-risk factors for preeclampsia. Fifty subjects received L-arginine, beginning from the 20th week of gestation. An additional 50 patients received homologated placebo. RESULTS: The placebo group had a higher number of cases of preeclampsia (11/47) compared with the L-arginine group (3/49, P = 0.01). Birth weight was higher in the L-arginine group and there was a smaller number of preterm births (P = 0.03). CONCLUSION: L-arginine is effective for preventing preeclampsia.

Serum complement C3c concentration in non-obese young insulin-resistant Mexicans.

The aim of this study was to compare the serum complement C3 concentration between non-obese young insulin-sensitive and insulin-resistant Mexicans. A cross-sectional study was carried out in 28 healthy, non-obese [Body mass index (BMI) < 26 kg/m2] young (age 19-25 yr), male volunteers to measure the serum C3 concentration. In accordance with the constant for rate serum glucose disappearance (KITT) obtained from the insulin tolerance test, the subjects were divided into quartiles, considering as insulin-resistant individuals those in quartile 1, and insulin-sensitive subjects those in quartile 4. Serum C3c concentration was measured by a nephelometric method. Other biochemical characteristics were measured, like lipid profile and uric acid using enzymatic techniques. The serum C3 concentrations were similar (p = 0.949) between insulin-resistant and insulin-sensitive groups respectively (1.4 +/- 0.2 vs 1.3 +/- 0.1 g/l). There were no significant correlations between serum C3 concentrations and serum glucose, insulin levels, KITT and lipid profile. In conclusion, the serum complement C3c concentrations were similar between non-obese young insulin-sensitive and insulin-resistant Mexicans.

[Effect of oral administration of ascorbic acid on insulin sensitivity and lipid profile in obese individuals]. / Efecto de la administración oral de ácido ascórbico sobre la sensibilidad a la insulina y el perfil de lípidos en individuos con obesidad.

BACKGROUND: The aim of this study was to identify the effect of an oral ascorbic acid (AA) supplement on lipid profile and insulin sensitivity in obese people. RESEARCH DESIGN AND METHODS: A randomized double-blind clinical trial placebo controlled was performed in 16 obese male volunteers [body mass index (BMI) 30-40 kg/m2]. Eight received orally 1 g of AA daily for four weeks and the other eight volunteers received placebo by the same scheme and period of time. Before and after the pharmacological intervention were measured total cholesterol, high-density-lipoprotein (HDL) cholesterol, triglycerides, glucose, creatinine and uric acid. Low-density-lipoprotein (LDL) cholesterol and very-low-density-lipoprotein (VLDL) triglycerides were calculated using formulas. In order to assess insulin sensitivity before and after the intervention, the steady-state glucose (SSG) was calculated from the insulin suppression test modified with octreotide. RESULTS: There were not significant differences in clinical characteristics between both groups. Basal metabolic profile and SSG were similar between both groups. There were not significant differences in both groups between before and after the intervention in metabolic profile and insulin sensitivity. CONCLUSION: AA did not modify the lipid profile nor insulin sensitivity in the group of obese people studied.

Serum leptin levels and the severity of preeclampsia.

The aim of this study was to evaluate the serum leptin levels in preeclampsia patients and in normotensive pregnant women, as well as, to assess an association with the severity of the disease. A cross-sectional study was carried out in 14 patients with mild preeclampsia, 12 with severe preeclampsia, and in 32 normotensive pregnant women during the third trimester of pregnancy. Rigorous criteria of selection were considered. The leptin levels were tested by an enzyme-linked immunosorbent method. There were no significant differences in serum leptin concentrations between the patients with mild preeclampsia [13.6 +/- 11.2 (95% CI, 7.7-19.4) ng/mL], severe preeclampsia [14.8 +/- 11.5 (95% CI, 8.2-21.3) ng/mL] and normotensive pregnant women [12.5 +/- 7.9 (95% CI, 9.7-15.2) ng/mL]. In conclusion, serum leptin levels were similar in the patients with different grades of preeclampsia and normotensive pregnant women.

Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects.

The objective of this study was to assess insulin sensitivity and cortisol concentration in healthy subjects with 24-hr sleep deprivation. A randomised, single-blind, controlled clinical trial was performed in 28 healthy subjects. Fourteen individuals were studied before and after 24-hr sleep deprivation and 14 volunteers with normal sleep periods (NSP) as a control group. Serum creatinine, uric acid, total cholesterol, high-density lipoprotein cholesterol, and triglyceride concentrations were measured in both groups. Insulin suppression test modified with octreotide (IST) and cortisol levels were performed before and after 24-hr sleep deprivation or NSP. Clinical and metabolic characteristics of the subjects in both groups are similar. Steady-state glucose (SSG) concentration of the IST was significantly higher after 24-hr sleep deprivation (5.7+/-2.1 vs 6.7+/-2.2 mmol/l; p=0.01). SSG level was similar before and after NSP (5.0+/-2.1 vs 5.0+/-1.8 mmol/l, respectively; p=0.91). There were not significant differences in cortisol levels between initial and final tests in both groups. In conclusion, 24-hr sleep deprivation decreased the insulin sensitivity in healthy subjects without changes in cortisol levels.

Comparison between usual and low doses of insulin in the assessment of insulin sensitivity with a short insulin tolerance test in obese women.

BACKGROUND: The objective of this study is to compare, in obese women, the assessment of insulin sensitivity and the presence of hypoglycemia between the usual and low doses of insulin used in the short insulin tolerance test (ITT). METHODS: The patients were 12 obese women on whom a randomized, double-masked, auto-controlled clinical trial was carried out. An ITT was performed on each volunteer in duplicate with insulin at 0.1 (usual dose) or 0.05 U/kg (low dose). RESULTS: The constant for the rate serum glucose disappearance calculated for the ITT was not significantly different between both tests (4.3 +/- 0.5 vs. 4.4 +/- 1.0%/min, usual dose and low dose of insulin, respectively; p = 0.49). There was a significant correlation between both tests (r = 0.59, r2 = 0.34, p < 0.05). Differences between both tests had estimated limits of agreement of -0.97 to 0.65%/min. Between tests, the coefficient of variation was 16%. No subject developed hypoglycemia with any of the ITT measurements employing usual or low doses of insulin. CONCLUSIONS: We recommend a low dose of insulin in the assessment of insulin sensitivity with ITT in obese people. In our study usual and low doses of insulin used in the ITT were safe and had similar results between both doses for assessing insulin sensitivity.