Feasibility Study of Two 12-Month Lifestyle Programs Combining Diet and High-Intensity Exercise to Achieve Type 2 Diabetes Remission

What this Trial Is About

This research aims to test the feasibility of a 12-month, two-group lifestyle intervention designed to induce and maintain remission of type 2 diabetes T2D. The study focuses on adults recently diagnosed with T2D who are overweight or obese and not on insulin therapy. It explores different diet compositions combined with high-intensity exercise to find the best approach to support remission and improve metabolic health. The findings will guide a larger 24-month trial with more groups. Participants will first follow a very low-calorie diet VLCD for 12 weeks. Then they will be randomly assigned to one of two groups for the next phase one group will transition to a carbohydrate-rich diet 50-55% carbs combined with high-intensity exercise, and the other will switch to a carbohydrate-reduced diet 25-30% carbs with the same exercise program. Both groups receive structured support, including meal boxes, supervised and unsupervised exercise sessions, and ongoing dietary guidance over 52 weeks. Throughout the study, participants will attend regular visits for assessments including diet and exercise adherence, blood tests, body measurements, and metabolic tests like the Mixed Meal Tolerance Test MMTT. Researchers will monitor safety, recruitment, retention, and participant experiences. Data on blood sugar control, weight changes, body composition, cardiovascular health, and quality of life will also be collected. The total study duration is about 52 weeks with a follow-up interview three months after completion.

A Feasibility Study of Optimal Non-Pharmacological Lifestyle Modifications in People With Type 2 Diabetes