The Effect of a Mediterranean Intermittent Fasting Diet Compared to Weight-reducing Medication on Liver Fibrosis in People With Type 2 Diabetes and Overweight (MEDFAST-study)

PHASE4RecruitingINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 14, 2025

Primary Completion Date

July 31, 2026

Study Completion Date

March 31, 2027

Conditions
Diabetes Mellitus, Type 2Liver FibrosisLiver SteatosesHepatic SteatosisHepatic FibrosisOverweight or ObesityMASLDMASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease
Interventions
OTHER

early time restricted Mediterranean diet

Participants will start with a calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating) for a period of six months. Participants are asked to stop eating at 6PM. This results in a daily fasting window of approximately 14 hours. A daily caloric intake of 500 kcal compared to the calculated energy requirement is assumed to stimulate weight loss.

DRUG

Mysimba

Participants will take Mysimba twice daily at a total dose of 32 mg/360 mg naltrexone/bupropion per day for a duration of six months. The dosage will be built up in the first month following the stepped care approach used in the SmPC. Participants receive usual care, including the advice of 60 minutes of exercise per day and standard dietary recommendations according to the guidelines for the Dutch population.

Trial Locations (1)

3045 PM

RECRUITING

Franciscus, Rotterdam

All Listed Sponsors
lead

Carmen Dietvorst

OTHER