Effectiveness of acupuncture as adjunctive therapy in type 2 diabetic: Study protocol for a randomized controlled trial.

INTRODUCTION: The incidence of type 2 diabetes mellitus is increasing worldwide. The literature suggests that acupuncture is a possible complementary therapy for type 2 diabetes mellitus. This study aims to determine the effectiveness of acupuncture as an adjunctive therapy on homeostasis model assessment-insulin resistance (HOMA-IR), and health-related quality of life (HRQoL) in patients with type 2 diabetes mellitus. MATERIALS AND METHODS: This randomized, double-blind, placebo controlled, and parallel design trial will be carried out in a public university teaching hospitals in Malaysia. Eligible type 2 diabetes mellitus subjects will be randomly assigned to receive either acupuncture (n = 30) or a placebo (n = 30). The intervention is carried out using press needle or press placebo on abdomen area (10 sessions of treatment). Both groups will continue with their routine diabetes care. Primary outcome of HOMA-IR will be measured at the time of recruitment (-week 0), and after completion of 10 sessions (week 7) of the treatment. Additionally, secondary outcome of HRQoL will be measured at the time of recruitment (-week 0), after completion of 5 sessions (week 3/4), and 10 sessions (week 7) of the treatment. Any adverse event will be recorded at every visit. DISCUSSION: The findings of this study will provide important clinical evidence for the effect of acupuncture as adjunctive therapy on HOMA-IR, adiposity and HRQoL of type 2 diabetes mellitus. TRIAL REGISTRATION NUMBER: NCT04829045.

A 16-Week Home-Based Progressive Resistance Tube Training Among Older Adults With Type-2 Diabetes Mellitus: Effect on Glycemic Control.

Research has proven that aerobic exercise improves glucose homeostasis among patients with type 2 diabetes mellitus (T2DM). Elastic resistance (tube or band) is suggested as a good alternative for home-based strength training among older adults including those with T2DM due to its low cost, simplicity, portability, and versatility. This study aimed to measure the effects of 16-week home-based progressive resistance training (PRT), using a resistance tube on glucose homeostasis and cardiovascular risk factors among older adults with T2DM. A total of 70 participants aged 61.68 (5.50) years with T2DM were assigned to the intervention (n = 35) and control (n = 35) groups in this quasi-experimental trial. The intervention group underwent 16 weeks of home-based PRT using a resistance tube. Significant improvements in HbA1c (-1.34% point, p < 0.001), fasting blood glucose (-1.30 mmol/L, p < 0.001), and systolic blood pressure (-1.42 mmHg, p < 0.05) were observed after 16 weeks of intervention. However, no significant changes were observed in lipid profile, diastolic blood pressure, resting heart rate, and ankle-brachial index. The finding suggests that 16 weeks of home-based PRT using a resistance tube has the potential to improve glycemic control and reduce systolic blood pressure among older adults with T2DM and caused no adverse events.

Effect of Cosmos caudatus (Ulam raja) supplementation in patients with type 2 diabetes: Study protocol for a randomized controlled trial.

BACKGROUND: Type 2 diabetes mellitus is a major health threat worldwide. Cosmos caudatus is one of the medicinal plants used to treat type 2 diabetes. Therefore, this study aims to determine the effectiveness and safety of C. caudatus in patients with type 2 diabetes. Metabolomic approach will be carried out to compare the metabolite profiles between C. Caudatus treated diabetic patients and diabetic controls. METHODS AND DESIGN: This is a single-center, randomized, controlled, two-arm parallel design clinical trial that will be carried out in a tertiary hospital in Malaysia. In this study, 100 patients diagnosed with type 2 diabetes will be enrolled. Diabetic patients who meet the eligibility criteria will be randomly allocated to two groups, which are diabetic C. caudatus treated(U) group and diabetic control (C) group. Primary and secondary outcomes will be measured at baseline, 4, 8, and 12 weeks. The serum and urine metabolome of both groups will be examined using proton NMR spectroscopy. DISCUSSION: The study will be the first randomized controlled trial to assess whether C. caudatus can confer beneficial effect in patients with type 2 diabetes. The results of this trial will provide clinical evidence on the effectiveness and safety of C. caudatus in patients with type 2 diabetes. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02322268.

Practice Of Self-Monitoring Blood Glucose Among Insulin-treated Diabetic Patients In Hospital Serdang

Background: Diabetes Mellitus (DM), characterised by chronic hyperglycaemia, exposes patients to acute and chronic complications, such as hypoglycaemia and vascular complications, respectively. The latter is associated with the degree of glycaemic control. Glycated haemoglobin (HbA1c) indicates long-term glycaemic control of the preceding 2-3 months. The practice of self-monitoring blood glucose (SMBG) is essential for insulin-treated diabetic patients to achieve optimum glycaemic control and prevent hypoglycaemia. Aim: The study aimed to determine the SMBG practice and frequency and its association with HbA1c and factors in insulin-treated diabetic patients. Methods: This was a cross-sectional study of insulin-treated diabetic patients attending follow-up at the diabetic clinic of Hospital Serdang from April 2015 to August 2015. Consented eligible patients completed validated selfadministered questionnaires. Patients’ HbA1c results were obtained from the hospital information system. Results: Ninetyone of 137 (66%) patients practiced SMBG and 46 (34%) did not. Although 82% had seen diabetic nurses, 54% of patients did not alter their treatment accordingly. Neither the practice nor the frequency of SMBG was significantly associated with differences in HbA1c levels (p=0.334 and p=0.116 respectively). Ethnicity and household income significantly affected SMBG practice. The presence and frequency of hypoglycaemia significantly increased the likelihood of SMBG practice (p<0.001) and frequency (p<0.001). Conclusions: The prevalence of SMBG practice in diabetic patients on insulin was 66%. However, SMBG was not followed by proper treatment alteration in 54% of patients. There was no association between SMBG practice and frequency with good glycaemic control. Hypoglycaemia significantly affected the practice and frequency of SMBG.

Eight Weeks of Cosmos caudatus (Ulam Raja) Supplementation Improves Glycemic Status in Patients with Type 2 Diabetes: A Randomized Controlled Trial.

Objectives. Optimizing glycemic control is crucial to prevent type 2 diabetes related complications. Cosmos caudatus is reported to have promising effect in improving plasma blood glucose in an animal model. However, its impact on human remains ambiguous. This study was carried out to evaluate the effectiveness of C. caudatus on glycemic status in patients with type 2 diabetes. Materials and Methods. In this randomized controlled trial with two-arm parallel-group design, a total of 101 subjects with type 2 diabetes were randomly allocated to diabetic-ulam or diabetic controls for eight weeks. Subjects in diabetic-ulam group consumed 15 g of C. caudatus daily for eight weeks while diabetic controls abstained from taking C. caudatus. Both groups received the standard lifestyle advice. Results. After 8 weeks of supplementation, C. caudatus significantly reduced serum insulin (-1.16 versus +3.91), reduced HOMA-IR (-1.09 versus +1.34), and increased QUICKI (+0.05 versus -0.03) in diabetic-ulam group compared with the diabetic controls. HbA1C level was improved although it is not statistically significant (-0.76% versus -0.37%). C. caudatus was safe to consume. Conclusions. C. caudatus supplementation significantly improves insulin resistance and insulin sensitivity in patients with type 2 diabetes.

Dietary compliance, dietary supplementation and traditional remedy usage of type 2 diabetic patients with and without cardiovascular disease.

This analytical cross-sectional study examined the nutrient intakes, dietary compliance, dietary supplementation and traditional remedy usage in type 2 diabetes mellitus (T2DM) patients from selected tertiary hospitals in multi-racial Malaysia. We compared the different characteristics of T2DM patients with and without cardiovascular disease (CVD). Socio-demographic status, dietary intakes, dietary supplementation, traditional remedy use, medical history, anthropometric measurements and clinical characteristics were obtained from face-to-face interviews. A total of 313 patients who were treated for T2DM participated in this study, in which 36.1% of them had CVD. The mean age of study subjects was 55.7 ± 9.2 years; mean diabetes duration was 10.1 ± 8.1 years; 52.1% were females; and 47.0% were Malays. The mean total energy intake of the subjects was 1674 ± 694 kcal/day, and patients with CVD consumed higher total calories (p = 0.001). Likewise, the mean carbohydrate, protein and total fat intake of CVD patients were significantly higher than non-CVD patients (p < 0.05), while mean intakes of cholesterol, fibre, minerals and all vitamins were comparable between CVD and non-CVD patients. Regardless of CVD status, a notably high proportion of the subjects did not meet the recommendations of the Medical Nutrition Therapy Guidelines for Type 2 Diabetes for total energy, carbohydrate, protein, total fat, and fibre intakes. Meanwhile, 52.4% used at least one dietary supplement and 12.1% took single traditional remedy or in various combinations. Traditional remedies and supplement intake did not differ between CVD and non-CVD subjects. It is suggested that T2DM patients should be educated based on their personalized dietary intake, dietary supplementation and traditional remedy usage. The recommendations for T2DM patients shall be met to achieve the optimal metabolic goals and minimize the potential diabetic complications.

Metabolic syndrome components and prevalence of cardiovascular disease among type 2 diabetic patients in Malaysia.

Metabolic syndrome (MetS) is common among patients with type 2 diabetes mellitus (T2DM) and increases the risk of cardiovascular disease (CVD) and all-cause mortality. The objective of this study was to investigate the association between the components of MetS and the prevalence of CVD among patients with T2DM. We studied 313 patients aged > or = 30 years diagnosed with T2DM at two tertiary care hospitals. Patients were recruited by systematic random sampling. Clinical data was obtained using an interviewer-administered structured questionnaire and from a review of their medical records. MetS was diagnosed using NCEP ATP III, WHO, IDF and the new Harmonized definitions. Specific MetS components such as BMI, waist circumference, waist-to-hip ratio, hypertension, HDL-C and triglyceride levels were evaluated to determine if they had an association with CVD. Thirty-six point one percent of the subjects had CVD. The mean age of the subjects was 55.7 +/- 9.2 years and the mean duration of having diabetes was 10.1 +/- 8.1 years. The overall prevalences of MetS (> or = 3 of 5 components) (95% CI) were 96.1% (94.0-98.3), 95.8% (93.6-98.1), 84.8% (80.8-88.9) and 97.7% (96.1-99.4) using NCEP ATP III, WHO, IDF and Harmonized definitions, respectively. Patients with MetS had a higher prevalence of CVD using NCEP ATP III (98.2% vs 93.5%), WHO (98.2% vs 93.0%), IDF (87.6% vs 82.0%) and Harmonized criteria (98.2% vs 96.0%). The greater the number of MetS components, the greater the chance of having CVD using three definitions for diagnosing MetS: WHO, IDF and Harmonized (p < 0.05). MetS and the combination of the individual components of MetS were significantly associated with CVD among type 2 diabetic patients in Malaysia. Aggressive treatment of MetS components is required to reduce cardiovascular risk in T2DM.

The association of cardiovascular disease with impaired health-related quality of life among patients with type 2 diabetes mellitus.

INTRODUCTION: The aim of this study was to evaluate the health-related quality of life (HRQoL) of Malaysian patients with type 2 diabetes mellitus (T2DM) who have cardiovascular disease (CVD), as well as identify the determinants of HRQoL among this cohort of patients. METHODS: This study was an analytical cross-sectional study involving 313 patients aged 30-78 years (150 men, 163 women; mean age 55.7 ± 9.2 years) who were diagnosed with T2DM (mean duration of T2DM 10.1 ± 8.1 years) at two tertiary Malaysian government hospitals. The patients' sociodemographic, lifestyle, clinical and laboratory data were collected prospectively from medical records and via face-to-face interviews. HRQoL was assessed using the 15D instrument - a generic, 15-dimensional and standardised measure of HRQoL that can be used as both a profile and a single index score measure. RESULTS: T2DM patients with CVD were found to have significantly lower 15D HRQoL scores than their nonCVD counterparts (p < 0.001). The HRQoL of T2DM patients with CVD was significantly lower than those without CVD (p < 0.05) in all of the 15 dimensions of the 15D instrument. Multinomial logistic regression analysis using backward stepwise method revealed a significant association between CVD and impaired HRQoL (odds ratio [OR] 11.746, 95% confidence interval [CI] 4.898-28.167). Age (OR 1.095, 95% CI 1.054-1.137), duration of T2DM (OR 1.085, 95% CI 1.032-1.140), ethnicity (OR 0.411, 95% CI 0.187-0.903), body mass index (OR 1.074, 95% CI 1.006-1.148), and physical activity level (OR 3.506, 95% CI 1.415-8.689) were also significant predictors of HRQoL. CONCLUSION: In T2DM patients, the presence of CVD was significantly associated with a lower HRQoL. Therefore, the importance of tertiary prevention to minimise the potential deterioration of the HRQoL of T2DM patients with CVD should be highly emphasised.