Evaluation of 7-Ketolithocholic Acid with Diet and Exercise to Reduce Blood Sugar in Adults Diagnosed with Prediabetes

What this Trial Is About

Researchers are evaluating 7-Ketolithocholic Acid, a naturally occurring bile acid, to assess its potential metabolic benefits, particularly its ability to lower glucose levels in adults with prediabetes. The study aims to determine whether this treatment, combined with a low-glycaemic, calorie-restricted diet and increased physical activity, can reduce fasting plasma glucose and other metabolic markers. This research focuses on early intervention to potentially prevent or delay the onset of type 2 diabetes. Participants will be randomly assigned to one of two groups one receiving 400 mg of 7-Ketolithocholic Acid daily in coated tablet form, and the other receiving matching placebo tablets without the active ingredient. Both groups will follow a low-glycaemic, hypocaloric diet and recommended physical activity including aerobic exercise, resistance training, and flexibility activities. The study includes six visits over approximately 16 weeks, covering screening, enrollment, periodic monitoring, and end-of-treatment assessments. Throughout the study, participants will undergo laboratory tests including fasting plasma glucose, HbA1c, cholesterol levels, and oral glucose tolerance tests. Diaries for diet and physical activity will be maintained and verified at scheduled visits and phone calls. Researchers will monitor adverse events and medication use at each visit. The primary outcome is the change in fasting plasma glucose from baseline to week 12, with additional metabolic and body measurements assessed as secondary outcomes. The study duration per participant spans about four months from screening to end of study.

7-Ketolithocholic Acid in Prediabetes