Clinical Research Directory

Whole Food Fibers for Support of Key Gut Bacteria for Human Health

The purpose of this supplementation study is to understand how whole food fibers may affect gut microbiota composition and overall health. The investigators will enroll up to 24 people in this study. To be eligible, participants need to be between 18 and 65 years old, have a Body Mass Index of 25 to 35 kg/m², be prediabetic (HbA1c: 5.7 - 6.3), be free of any inflammatory bowel disease or any colon-related disease, be free of wheat allergens or intolerance, and not be pregnant or nursing. If participants have any questions about the criteria, they will ask the investigator consenting them. This is a randomized, cross-over, double-blind, clinical trial (RCT) that will last 12 consecutive weeks in total (4 weeks of treatment A + 4 weeks of washout + 4 weeks of treatment B). The order of the treatments will be randomly assigned before the beginning of the study. If proved right, this study will provide a science-based fiber reason why consumption of whole foods constitutes a better dietary approach than the current practice of adding soluble dietary fiber (inulin) alone to modulate gut microbiota for gut and whole-body health.

Real-World Outcomes of Tirzepatide in Pakistani Adults With Obesity, Prediabetes, and Type 2 Diabetes

This is a multicentre, prospective, observational study of the medicine tirzepatide as it is used in routine clinical care in Pakistan. Tirzepatide is already approved for type 2 diabetes and for obesity, but there is very little information on how it works for people in South Asia, and none from Pakistan specifically. This study aims to fill that gap. The study will follow 330 adults who are starting tirzepatide as part of their normal treatment, across ten diabetes and endocrinology centres in Pakistan. Everyone taking part has obesity, and they are grouped into three cohorts based on their blood sugar status at the start: obesity without diabetes, prediabetes with obesity, and type 2 diabetes with obesity. The study does not change anyone's treatment. The treating doctor decides whether to prescribe tirzepatide, at what dose, and for how long. The study simply observes and records what happens over 24 weeks, with assessments at the start, at Weeks 12 to 14, and at Weeks 24 to 26. The main things measured are the change in blood sugar control (HbA1c) in the diabetes cohort, and the change in body weight in the obesity and prediabetes cohorts. The study also looks at changes in blood pressure, cholesterol, and other measures, how well people stay on treatment, any side effects, and how participants feel about their treatment and quality of life. The findings will help doctors understand how tirzepatide performs in real-world care in Pakistan and inform its use in similar populations.