Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion (Mysimba) in People With Type 2 Diabetes and Overweight

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Netherlands
Franciscus
RECRUITING
Rotterdam
Contact Information
Primary
Carmen Dietvorst, MSc.
c.dietvorst@franciscus.nl
+31108935192
Backup
Manuel Castro Cabezas, Dr.
m.castrocabezas@franciscus.nl
+31104616295
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2027-03
Participants
Target number of participants: 70
Treatments
Active_comparator: Dietary arm
Calorie restricted Mediterranean diet, with an eating window between 8AM till 6PM (early time-restricted eating)
Active_comparator: Pharmacological arm
32 mg/360 mg naltrexone/bupropion (Mysimba)
Sponsors
Leads: Carmen Dietvorst

This content was sourced from clinicaltrials.gov