Clinical Research Directory

Low-Dose Semaglutide for Weight Loss in Obese Non-Diabetic Pakistani Adults

This prospective, open-label, single-arm, single-center interventional pilot trial aims to evaluate the efficacy and safety of low-dose semaglutide for weight loss and cardiometabolic improvement in obese Pakistani adults without type 2 diabetes mellitus. The study will be conducted at the Asian Institute of Medical Sciences (AIMS), Hyderabad, Sindh, Pakistan. A total of 60 obese adults aged 18 years or older with a body mass index (BMI) of 27.5 kg/m² or greater according to World Health Organization Asian cutoffs and without type 2 diabetes mellitus (fasting blood glucose \<126 mg/dL and HbA1c \<6.5%) will be enrolled. Eligible participants will receive once-weekly subcutaneous semaglutide following a standard dose titration schedule of 0.25 mg weekly for four weeks, 0.5 mg weekly for four weeks, and 1.0 mg weekly for the remaining 16 weeks, for a total treatment duration of 24 weeks. All participants will receive standardized lifestyle counseling, including a hypocaloric diet with a 500-750 kcal/day deficit and at least 150 minutes per week of moderate-intensity physical activity. The primary outcome is the percentage change in body weight from baseline to 24 weeks. Secondary outcomes include changes in body mass index, waist circumference, systolic and diastolic blood pressure, lipid profile (total cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides), liver enzymes (alanine aminotransferase and aspartate aminotransferase), and quality of life. Safety will be assessed through continuous monitoring of adverse events and adverse drug reactions with causality assessment using the Naranjo Adverse Drug Reaction Probability Scale. Clinical and laboratory assessments will be conducted at baseline, 12 weeks, and 24 weeks. Data will be analyzed using descriptive and inferential statistics, including paired t-tests or non-parametric equivalents and repeated measures analysis, with a significance level of p \< 0.05. The study will be conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki, with approval from the AIMS Institutional Review Board and written informed consent obtained from all participants. The trial aims to generate locally relevant clinical evidence on the effectiveness and safety of low-dose semaglutide for obesity management in non-diabetic Pakistani adults.

Athlete Biochemical Monitoring and Nutritional Support

The objective of this study is to evaluate the efficacy of physiological and biochemical monitoring along with nutritional support in improving the performance and well-being of female weightlifters during the critical weight reduction phase before competition. It also seeks to determine the safety and potential benefits of the personalized nutritional interventions. The primary questions this study aims to address are: Does personalized nutritional support, informed by physiological and biochemical monitoring, reduce the incidence of fatigue and improve sleep quality in female weightlifters during the pre-competition period? How do serum indicators change in response to the nutritional interventions, and what does this indicate about the athletes' health and performance? What are the perceived benefits and any potential adverse effects reported by the participants receiving the nutritional support? To assess the impact of the intervention, researchers will compare the outcomes of the experimental group, which receives the tailored nutritional support, to those of the control group, which follows standard practices without additional intervention. Participants will be required to: Consume the nutritional supplements or maintain their regular diet as assigned for the duration of the 1-month study. Attend scheduled visits to the research facility every two weeks for comprehensive health assessments, including blood tests for serum indicators and evaluations of fatigue levels and PSQI scores. Record their daily experiences, including dietary adherence, training intensity, perceived fatigue, sleep patterns, and any other relevant observations in a personal diary. By conducting this randomized controlled trial, the study will provide valuable insights into the role of targeted nutritional support in enhancing athletic performance and overall health during the demanding pre-competition weight reduction period.