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)

Last updated: July 7, 2025
Sponsor: Carmen Dietvorst
Overall Status: Active - Recruiting

Phase

4

Condition

Obesity

Diabetes Prevention

Diabetes And Hypertension

Treatment

Mysimba

early time restricted Mediterranean diet

Clinical Study ID

NCT06845345
2024-519774-40-00
2024-519774-40-00
  • Ages 18-75
  • All Genders

Study Summary

In the Netherlands, there are many people with type 2 diabetes. More than half of these people also have fatty liver. This is a build-up of fat in the liver (steatosis) and can lead to long-term scarring (fibrosis) and even death of the liver. Losing weight can help reduce this. Losing weight can be done with medication such as Mysimba®, which is often prescribed to people with type 2 diabetes, but losing weight can also be done with diet. In this study, the investigators want to combine a Mediterranean diet (with lots of vegetables, fruits, whole grain products, nuts and olive oil) with intermittent fasting. In addition participants are not allowed to eat after the evening meal. The investigators will compare this with a group of participants receiving Mysimba®, to see if a diet with intermittent fasting might be better for reducing liver steatosis and fibrosis in people with type 2 diabetes.

Eligibility Criteria

Inclusion

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

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 limitedto: 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, hepaticencephalopathy 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 usingcorticosteroids)

  • 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 tocontraindication)

  • Known or suspected excessive alcohol consumption (>21 drinks/week for males or >14drinks/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 anyinfluence on the patient's weight, in the opinion of the investigator, are allowed.

  • Participants with a history or evidence of any other clinically significantcondition or planned or expected procedure that in the opinion of the investigator,may compromise the patient's safety or ability to complete the study

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: Mysimba
Phase: 4
Study Start date:
April 14, 2025
Estimated Completion Date:
March 31, 2027

Connect with a study center

  • Franciscus

    Rotterdam, 3045 PM
    Netherlands

    Active - Recruiting

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