Comparing diet and medication for weight loss in people with type 2 diabetes and liver scarring
Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion (Mysimba) in People With Type 2 Diabetes and Overweight
This study tests whether a Mediterranean diet with intermittent fasting or the medication Mysimba® helps people with type 2 diabetes and liver scarring lose weight and improve their liver health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Franciscus Gasthuis Academic / other |
| Locations | 1 site (Rotterdam) |
| Trial ID | NCT06845345 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a Mediterranean diet combined with intermittent fasting versus the medication Mysimba® on weight loss in individuals with type 2 diabetes and moderate to severe liver fibrosis. Participants will be assigned to either the dietary intervention or the medication group to evaluate which approach is more effective in reducing fatty liver and liver scarring. The study aims to provide insights into the best strategies for managing weight and liver health in this population.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 with type 2 diabetes, moderate to severe liver fibrosis, and a BMI over 27 kg/m2.
Not a fit: Patients with significant liver pathology, such as cirrhosis or active liver disease, as well as those with certain comorbidities or language barriers, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective weight loss strategy for patients with type 2 diabetes and liver scarring, potentially improving their liver health and overall well-being.
How similar studies have performed: Other studies have shown promising results with dietary interventions for weight loss in diabetes, but this specific combination of Mediterranean diet and intermittent fasting is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 2 diabetes * Moderate to severe liver fibrosis (LSM \>8.0 kPa and \<13.6 kPa) * BMI \> 27 kg/m2 * Aged 18-75 years * Written informed consent Exclusion Criteria: * An insufficient comprehension of the Dutch language (spoken and written) * Female who is pregnant, breast-feeding or intends to become pregnant * Participants with an established diagnosis of liver pathology like, but not limited to: Hepatitis B, Hepatitis C, Autoimmune hepatitis, Wilson's disease, Hemochromatosis, Primary biliary cholangitis, Primary sclerosing cholangitis, Alcoholic liver disease * History of liver transplant, or current placement on a liver transplant list * History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding * Participants with active HIV infection and/or treatment * Participants with diagnosed malignancies with or without active treatment * Participants with history or pre-existing renal disease (eGFR \<30 mL/min/1.73 m2) * Participants with corticosteroid induced diabetes (while still using corticosteroids) * Participants using GLP-1 agonists for less than 3 months or not yet on a stable dose * Participants using MAO-inhibitors, opioids and/or methadone (due to contraindication) * Known or suspected excessive alcohol consumption (\>21 drinks/week for males or \>14 drinks/week for females. One drink is equivalent to 10 grams of alcohol) * Previous or planned (during the trial period) obesity treatment with surgery. However, previous interventions that, due to reversal or removal, do not have any influence on the patient's weight, in the opinion of the investigator, are allowed. * Participants with a history or evidence of any other clinically significant condition or planned or expected procedure that in the opinion of the investigator, may compromise the patient's safety or ability to complete the study
Where this trial is running
Rotterdam
- Franciscus — Rotterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Manuel Castro Cabezas, Dr. — Franciscus
- Study coordinator: Carmen Dietvorst, MSc.
- Email: c.dietvorst@franciscus.nl
- Phone: +31108935192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.