The Effect of Diet or Medication to Lose Weight in People With Type 2 Diabetes and Liver Scarring

Launched by CARMEN DIETVORST · Feb 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different approaches to help people with type 2 diabetes and liver scarring (also known as liver fibrosis) lose weight. Researchers want to see if a specific diet combined with intermittent fasting (which means eating only during certain hours of the day) is more effective than a medication called Mysimba® in reducing fat in the liver and improving liver health. The diet focuses on healthy foods, like vegetables, fruits, whole grains, and olive oil, while participants will also avoid eating after dinner.

To join the study, participants must be between 18 and 75 years old, have type 2 diabetes, and have moderate to severe liver fibrosis. They should also have a body mass index (BMI) over 27, which means they are overweight or obese. Participants will be closely monitored throughout the trial, and those who qualify will have the chance to either follow the diet plan or take the medication. It's important to know that certain health conditions and treatments might exclude someone from participating, so a thorough screening will be done. This study aims to find the best way to improve liver health and overall well-being for people living with these conditions.

Gender

ALL

Eligibility 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