Ongoing Clinical Trials for Increased Body Mass Index
There is currently 1 ongoing clinical trial investigating treatments for people with increased body mass index (BMI), specifically focusing on individuals who are overweight and have type 2 diabetes and liver fibrosis. The trial is comparing a Mediterranean diet with intermittent fasting to a medication called Mysimba to see which approach is more effective in improving liver health.
Clinical trial locations
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
This trial is taking place in the Netherlands and is designed to help people who are overweight and have both type 2 diabetes and liver fibrosis, which is a type of liver scarring. The study compares two different approaches: a special eating plan called the Mediterranean diet combined with intermittent fasting, and a medication called Mysimba.
Main inclusion criteria: To join this trial, participants must have type 2 diabetes, which is a condition where the body doesn’t use insulin properly, leading to high blood sugar levels. They must also have moderate to severe liver fibrosis, measured by a test called FibroScan with results between 8.0 and 13.6 kPa. Participants need to have a Body Mass Index greater than 27 kg/m², which indicates they are overweight, and must be between 18 and 75 years old. Both men and women can participate.
Main exclusion criteria: People cannot join if they have a BMI of 30 kg/m² or more, which is considered obese. Those with a BMI between 27 and 30 kg/m² who also have other weight-related health issues like type 2 diabetes, abnormal blood fat levels, or controlled high blood pressure are also excluded. Additionally, people without significant liver fibrosis, as measured by a FibroScan result of less than 8.0 kPa, cannot participate.
Focus and goal: The trial aims to find out which treatment is more effective in improving liver health in people with type 2 diabetes and excess weight. Participants will follow one of two treatments for six months. The Mediterranean diet focuses on fruits, vegetables, whole grains, and healthy fats, and is combined with intermittent fasting, where eating is restricted to certain times of the day. The other treatment involves taking Mysimba, a medication containing bupropion hydrochloride and naltrexone hydrochloride in prolonged-release tablets that release the medication slowly over time.
Investigational treatments: Mysimba is a combination medication that works to reduce appetite and control cravings by influencing the brain’s reward system and appetite control centers. The trial also tests an early time-restricted eating Mediterranean diet, which combines the principles of the Mediterranean diet with intermittent fasting. Participants eat all their meals within a specific time frame each day. Throughout the study, researchers will measure changes in liver stiffness using FibroScan, as well as other health factors like body weight, cholesterol levels, blood sugar, physical activity, sleep patterns, and quality of life to see how these treatments affect overall well-being.
Summary
Currently, there is one clinical trial available for people with increased body mass index, specifically targeting those who are overweight and have both type 2 diabetes and liver fibrosis. This trial, conducted in the Netherlands, offers an interesting comparison between a lifestyle intervention using a Mediterranean diet with intermittent fasting and a pharmacological approach using Mysimba medication. The study reflects growing interest in understanding how different treatment strategies can address not only weight management but also related complications such as liver fibrosis in people with type 2 diabetes. This research may provide valuable insights into whether dietary changes or medication is more effective for improving liver health in this specific patient population.