Clinical trial NCT06845345: The Effect of Diet or Medication to Lose Weight in People With Type 2 Diabetes and Liver Scarring
Official title: Effect of Mediterranean Diet Combined With Intermittent Fasting on Liver Fibrosis Compared to Naltrexone/Bupropion (Mysimba) in People With Type 2 Diabetes and Overweight
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Liver Fibrosis
Liver Steatoses
Hepatic Steatosis
Hepatic Fibrosis
Overweight or Obesity
Keywords: diabetes
liver diseases
liver fibrosis
intermittent fasting
mediterranean diet
mysimba
lifestyle
Lead sponsor: Franciscus Gasthuis
Sponsor class: OTHER
First posted: 2025-02-25
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 and can lead to long-term scarring 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 fatty liver and liver scarring in people with type 2 diabetes.


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

Primary outcomes:
measure: Between-group difference in liver fibrosis during six months
timeFrame: Change from baseline to 6 months
Secondary outcomes:
measure: Between group difference in liver steatosis during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in weight during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in height during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in waist circumference during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in body composition during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in grip strength during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in glycaemic regulation during six months
timeFrame: Change from baseline to 6 months
measure: Between-group differences in cholesterol during six months
timeFrame: Change from baseline to 6 months
measure: Between-group differences in lipoproteins during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in blood pressure during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in liver enzymes during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in renal function during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in blood count during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in physical activity during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in lifestyle factors during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in quality of life during six months
timeFrame: Change from baseline to 6 months
measure: Between-group difference in patient satisfaction during six months
timeFrame: Change from baseline to 6 months
Other outcomes:
measure: Shift in liver fibrosis severity during six months
timeFrame: Change from baseline to 6 months
measure: Drop-outs during six months
timeFrame: Change from baseline to 6 months
measure: Side effects during six months
timeFrame: Change from baseline to 6 months
Locations:
city: Rotterdam
country: Netherlands
facility: Franciscus
Study officials:
affiliation: Franciscus
name: Manuel Castro Cabezas, Dr.
role: PRINCIPAL_INVESTIGATOR
References: