Comparing diet and medication for weight loss in people with type 2 diabetes and liver scarring

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.