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Healthy Volunteer

Researchers are studying overweight adults aged 20 to 70 with type 2 diabetes to evaluate weight loss and diabetes remission through a total diet replacement program. The trial compares two methods of follow-up care: eHealth follow-up via an application and video meetings, and traditional face-to-face follow-up visits. A healthy control group with normal glucose levels is also examined once but does not receive any treatment or randomization. Participants replace their usual diet with a total diet replacement providing 850 kcal per day for three months, aiming for a weight loss of 15 kg and diabetes remission, defined as HbA1c below 48 mmol/mol without diabetes medication. If the weight loss goal is not met, two additional months of total diet replacement may be recommended. After this phase, food is gradually reintroduced, and an individually tailored energy plan helps prevent weight regain. If weight is regained later, a rescue plan with total diet replacement is offered. To support maintaining weight loss, all participants follow a cognitive behavioral therapy program, delivered either through the eHealth app or during face-to-face visits. Participants regularly record body weight, blood glucose, and blood pressure, with HbA1c measured at scheduled times. The eHealth group tracks these metrics daily via the app and has video appointments, while the face-to-face group attends medical office visits for assessments. Primary outcomes focus on HbA1c levels at 12 months, comparing the two follow-up groups. The trial lasts two years, with long-term monitoring planned through national diabetes registry data to compare outcomes with similar patients not in the study. The healthy control group is examined once after one year for comparison.

Age: 20Years - 70YearsAll GendersPhase Not Applicable
3 locations
Ornskoldsvik Clinical Trials | DecenTrialz