METHODS AND ANALYSIS: Primary outcomes focus on feasibility measures of recruitment, retention, implementation and acceptability of the intervention. Secondary outcomes will include blood pressure, cognitive function, body composition and physical function (including muscle strength and gait speed). Adherence to the dietary intervention will be assessed through collection of biological samples, 24-hour recall and Food Frequency Questionnaire. A subgroup of participants will also complete postintervention focus groups to further explore the feasibility considerations of executing a larger trial, the ability of these individuals to make dietary changes and the barriers and facilitators associated with implementing these changes.
ETHICS AND DISSEMINATION: Ethical approval has been obtained from Monash University Human Research Ethics Committee and Medical Research and Ethics Committee of Malaysia. Results of the study will be disseminated via peer-reviewed publications and presentations at national and international conferences.ISRCTN47562685; Pre-results.
METHODS: Using a 2-by-2-by-2 factorial design, we randomly assigned participants without cardiovascular disease who had an elevated INTERHEART Risk Score to receive a polypill (containing 40 mg of simvastatin, 100 mg of atenolol, 25 mg of hydrochlorothiazide, and 10 mg of ramipril) or placebo daily, aspirin (75 mg) or placebo daily, and vitamin D or placebo monthly. We report here the outcomes for the polypill alone as compared with matching placebo, for aspirin alone as compared with matching placebo, and for the polypill plus aspirin as compared with double placebo. For the polypill-alone and polypill-plus-aspirin comparisons, the primary outcome was death from cardiovascular causes, myocardial infarction, stroke, resuscitated cardiac arrest, heart failure, or revascularization. For the aspirin comparison, the primary outcome was death from cardiovascular causes, myocardial infarction, or stroke. Safety was also assessed.
RESULTS: A total of 5713 participants underwent randomization, and the mean follow-up was 4.6 years. The low-density lipoprotein cholesterol level was lower by approximately 19 mg per deciliter and systolic blood pressure was lower by approximately 5.8 mm Hg with the polypill and with combination therapy than with placebo. The primary outcome for the polypill comparison occurred in 126 participants (4.4%) in the polypill group and in 157 (5.5%) in the placebo group (hazard ratio, 0.79; 95% confidence interval [CI], 0.63 to 1.00). The primary outcome for the aspirin comparison occurred in 116 participants (4.1%) in the aspirin group and in 134 (4.7%) in the placebo group (hazard ratio, 0.86; 95% CI, 0.67 to 1.10). The primary outcome for the polypill-plus-aspirin comparison occurred in 59 participants (4.1%) in the combined-treatment group and in 83 (5.8%) in the double-placebo group (hazard ratio, 0.69; 95% CI, 0.50 to 0.97). The incidence of hypotension or dizziness was higher in groups that received the polypill than in their respective placebo groups.
CONCLUSIONS: Combined treatment with a polypill plus aspirin led to a lower incidence of cardiovascular events than did placebo among participants without cardiovascular disease who were at intermediate cardiovascular risk. (Funded by the Wellcome Trust and others; TIPS-3 ClinicalTrials.gov number, NCT01646437.).
AIM: To investigate the effects of food order on postprandial glucose (PPG) excursion, in Indian adults with normal (NL) and overweight/obese (OW) Body Mass Index.
METHODS: This randomised crossover study was conducted at a Malaysian university among Indian adults without diabetes. The participants consumed isocaloric test meals at three study visits based on randomised food orders: carbohydrate first/protein last (CF); protein first/carbohydrate last (CL); and a composite meal containing carbohydrate and protein (CM). Capillary blood glucose was measured at baseline, 30, 60, 90 and 120 minutes after starting the meal.
RESULTS: The CL food order had a blunting effect on PPG excursion at 30 and 60 minutes (p < 0.01). The CL food order resulted in lower glucose peak when compared with the CF and CM food order (p < 0.001). The CL food order resulted in lower incremental glucose peak (mmol/L) (NL: CF 3.9 ± 0.3, CM 3.0 ± 0.3, CL 2.0 ± 0.2; OW: CF 2.9 ± 0.3, CM 2.5 ± 0.3, CL 1.8 ± 0.2) and iAUC 0-120 min (mmol/Lxmin) (NL: CF 272.4 ± 26.7, CM 206.2 ± 30.3, CL 122.0 ± 14.8; OW: CF 193.2 ± 23.1, CM 160.1 ± 21.7, CL 113.6 ± 15.3) when compared with the CF food order (p < 0.001). The effect of food order on postprandial excursion did not differ between the NL (n = 14) and the OW (n = 17) groups.
CONCLUSION: In participants with normal and overweight/obese BMI, consuming food in the protein first/carbohydrate last order had the biggest effect in reducing PPG excursion.
METHODS: This cross-sectional study included 95 breast cancer survivors (age 53.7 ± 7.6 years) who have completed main cancer treatments for ≥6 months. Cancer survivors were recruited from two main government hospitals in Kelantan and Terengganu using a purposive sampling method.
RESULTS: According to the Harmonized criteria, the metabolic syndrome prevalence was 50.5%. Among those with metabolic syndrome, the most prevalent abnormal metabolic components were triglycerides (91.2%), fasting blood glucose (79.6%) and HDL-c level (78.4%). Except for total cholesterol and LDL-c, all other metabolic syndrome components were significantly different (p blood glucose and HDL-c level of the breast cancer survivors under their care to control the detrimental effect of metabolic syndrome.
OBJECTIVE: This study examines how patients with diabetes mellitus responded towards their clinical treatments, where the probability distribution of patients and the types of treatment received were derived from the Rasch probabilistic model.
METHODS: This is a retrospective study wherein data were collected from patients' medical records at a local public hospital in Selangor, Malaysia. Clinical and demographic information such as fasting blood glucose, hemoglobin A1c (HbA1c), family history, type of diabetes (type 1 or type 2), types of medication (oral or insulin), compliance with treatments, gender, race and age were chosen as the agents of measurement.
RESULTS: The use of Rasch analysis in the present study helped to compare the patients' responses towards the DM treatments and identify the types of treatment they received. Results from the Wright map show that a majority of the diabetes mellitus patients who were diagnosed with type 2 diabetes have no controlled readings of HbA1c during their first and second visits to the medical center. However, patients with a family history of diabetes mellitus who took oral medication have controlled readings of fasting blood glucose based on the probabilistic outcomes of the treatment received by the patients.
CONCLUSION: Controlled readings were found only in the readings of fasting blood glucose during the first and second visits, followed by family history, types of medication received, and compliance with the treatment. This study has recommended that type 2 patients with diabetes without a family history of diabetes mellitus need to exercise more control over the readings of HbA1c.