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Study on the Effects of a Mediterranean Diet with Intermittent Fasting vs. Bupropion and Naltrexone in Overweight Patients with Type 2 Diabetes and Liver Fibrosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a special diet and a medication on people who are overweight and have type 2 diabetes. The study is looking at how these treatments can help improve a condition called *liver fibrosis*, which is a type of liver damage. The medication being tested is called *Mysimba*, which contains two active ingredients: *bupropion hydrochloride* and *naltrexone hydrochloride*. These are taken in the form of prolonged-release tablets, meaning they release the medication slowly over time.

The purpose of the study is to compare the effectiveness of a Mediterranean diet combined with intermittent fasting to the medication Mysimba in improving liver fibrosis. Participants will follow one of these two treatments for six months. The Mediterranean diet is known for its focus on fruits, vegetables, whole grains, and healthy fats, and in this study, it will be combined with a method called intermittent fasting, where eating is restricted to certain times of the day. The study will measure changes in liver fibrosis using a method called *FibroScan*, which checks how stiff the liver is, as well as other health factors like body weight, cholesterol levels, and blood sugar.

Participants in the study will be adults aged 18 to 75 who have type 2 diabetes and a *Body Mass Index (BMI)* of 27 or higher, indicating they are overweight or obese. The study will also look at other aspects of health, such as physical activity, sleep patterns, and quality of life, to see how these treatments might affect overall well-being. The goal is to find out which treatment is more effective in improving liver health in people with type 2 diabetes and excess weight.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as having type 2 diabetes, moderate to severe liver fibrosis, a BMI greater than 27 kg/m², and being aged between 18 and 75 years.
Step 2
Initial assessment
An initial assessment is conducted to measure liver stiffness using a FibroScan, which is a non-invasive test that uses transient elastography to assess liver fibrosis.
Additional measurements include body weight, height, waist circumference, fat mass, lean body mass, and grip strength.
Step 3
Medication administration
Participants are administered Mysimba 8 mg/90 mg prolonged-release tablets orally. This medication contains bupropion hydrochloride and naltrexone hydrochloride.
The dosage and frequency of administration are determined by the study protocol and are followed throughout the trial duration.
Step 4
Dietary intervention
Participants follow an early time-restricted eating Mediterranean diet (eTRE-MD) for six months. This diet is designed to improve liver fibrosis and is compared to the effects of Mysimba.
Step 5
Ongoing assessments
Throughout the trial, liver fibrosis is monitored using FibroScan to measure liver stiffness.
Secondary assessments include liver steatosis, cardiovascular risk factors, and various laboratory measurements such as cholesterol levels, blood glucose, and liver enzymes.
Step 6
Physical activity and lifestyle monitoring
Participants' physical activity and sleep patterns are monitored.
Quality of life, patient satisfaction, and adherence to the dietary intervention are also evaluated.
Step 7
Completion of the trial
The trial is estimated to end on January 4, 2027. At the conclusion, final assessments are conducted to evaluate the effectiveness of the interventions on liver fibrosis and other health parameters.

Who can join the trial?

5 criteria

Must have Type 2 diabetes, which is a condition where the body doesn't use insulin properly, leading to high blood sugar levels.
Must have moderate to severe liver fibrosis. This means there is significant scarring in the liver, measured by a test called Fibroscan, with results between 8.0 and 13.6 kPa.
Must have a Body Mass Index (BMI) greater than 27 kg/m². BMI is a number calculated from a person's weight and height, used to determine if they are overweight or obese.
Must be aged between 18 and 75 years.
Both men and women can participate.

Who cannot join the trial?

3 criteria

People with a Body Mass Index (BMI) of 30 kg/m² or more. BMI is a measure that uses your height and weight to work out if your weight is healthy. A BMI of 30 or more is considered obese.
People with a BMI between 27 kg/m² and 30 kg/m² who also have one or more weight-related health issues. These issues can include type 2 diabetes (a condition where your body can't control blood sugar levels properly), dyslipidemia (an abnormal amount of fats in the blood), or regulated hypertension (high blood pressure that is controlled with medication).
People who do not have significant liver fibrosis. Liver fibrosis is a condition where the liver becomes scarred and stiff. It is measured using a test called Fibroscan, and a result of more than 8.0 kPa indicates significant fibrosis.

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Sint Franciscus Vlietland Groep Stichting
Rotterdam, The Netherlands

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Investigated drugs

Mysimba is a medication used in this trial to help manage weight in people who are overweight or obese. It is a combination of two active ingredients, naltrexone and bupropion, which work together to reduce appetite and control cravings. This medication is being compared to a specific diet to see how effective it is in improving liver health in people with type 2 diabetes. The trial also involves a specific dietary approach called the early time restricted eating Mediterranean diet (eTRE-MD). This diet combines the principles of the Mediterranean diet, which is rich in fruits, vegetables, whole grains, and healthy fats, with intermittent fasting. Participants follow a schedule where they eat all their meals within a certain time frame each day. This approach is being tested to see if it can improve liver fibrosis in people with type 2 diabetes and overweight.

What is already known about the treatment

Mysimba – This medication is taken orally in tablet form and is currently used in clinical settings to help manage weight in individuals who are obese or overweight with related health issues like type 2 diabetes. It is a combination of two active ingredients, naltrexone and bupropion, which work together to influence the brain's reward system and appetite control centers, helping to reduce food cravings and increase energy expenditure. Mysimba is classified as an anti-obesity agent and is being studied for its potential benefits in improving liver fibrosis in patients with type 2 diabetes.

Investigated diseases

Obesity
Obesity is a condition characterized by excessive body fat accumulation, typically defined by a Body Mass Index (BMI) of 30 kg/m² or more. It often develops gradually over time due to a combination of genetic, behavioral, and environmental factors. Obesity can lead to various health issues, including type 2 diabetes, heart disease, and certain types of cancer. It is associated with an increased risk of developing other conditions such as high blood pressure and dyslipidemia. The progression of obesity can be influenced by lifestyle factors, including diet and physical activity levels. Managing obesity often involves lifestyle changes to reduce weight and improve overall health.
Type 2 Diabetes
Type 2 diabetes is a chronic condition that affects the way the body processes blood sugar (glucose). It typically develops in adults, although it is increasingly seen in younger individuals due to rising obesity rates. In type 2 diabetes, the body either resists the effects of insulin or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to serious health problems, including heart disease, vision loss, and kidney disease. The condition often progresses gradually and can be managed with lifestyle changes and medication. Monitoring blood sugar levels is crucial for managing type 2 diabetes effectively.
Liver Fibrosis
Liver fibrosis is the excessive accumulation of extracellular matrix proteins, including collagen, in the liver. It is a response to chronic liver injury and can result from various conditions, such as chronic hepatitis, alcohol abuse, or non-alcoholic fatty liver disease. Over time, liver fibrosis can progress to cirrhosis, which is characterized by severe scarring and impaired liver function. The progression of liver fibrosis is influenced by the underlying cause and the individual's overall health. Early stages of fibrosis may not present symptoms, but as it advances, it can lead to liver dysfunction and other complications. Regular monitoring and lifestyle changes can help manage the progression of liver fibrosis.