RecruitingOBSERVATIONAL

Who Will Benefit From Bariatric Surgery for Diabetes?

This research aims to understand why some individuals with type 2 diabetes find that their condition improves or even goes away after having a specific type of weight-loss surgery called a Roux-en-Y gastric bypass. The study focuses on several factors that might influence this outcome. Researchers are investigating how the way fat is stored in the body, certain genetic markers linked to type 2 diabetes, and changes in genes and gut hormones after a meal could affect how well the surgery works for diabetes remission. By understanding these differences, scientists hope to predict who might benefit most from this surgery in the future, ultimately helping more people manage their type 2 diabetes effectively.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

210

Start

01 Oct 2018

Estimated completion

05 Oct 2028

Diabetes Mellitus, Type 2 Obesity

What is this study about?

This study is particularly interested in people who have type 2 diabetes and are considering or have had a specific weight-loss operation called Roux-en-Y gastric bypass surgery. While this surgery is known to help many people lose weight, it can also significantly improve or even reverse type 2 diabetes in some cases. The main goal of this research is to figure out why some people experience this great benefit when others don't.

The researchers are looking into several aspects. They want to understand how the distribution of fat in your body (where you carry your weight), certain genetic clues you inherited, and changes in how your body handles food and hormones after surgery might affect the success of the diabetes treatment. They also aim to see if there are tiny changes in how your genes work (called epigenetic and transcriptomic changes) that play a part.

Ultimately, by gathering all this information, the study hopes to create a clearer picture of who is most likely to see their type 2 diabetes go into remission after Roux-en-Y gastric bypass surgery. This knowledge could help doctors and patients make more informed decisions about treatment options for type 2 diabetes linked to obesity.

Key takeaways

This study aims to understand why weight-loss surgery helps some people with type 2 diabetes more than others.
It's looking at factors like body fat, genes, and gut hormones.
The goal is to predict who might benefit most from Roux-en-Y gastric bypass for diabetes.
Participants include adults with type 2 diabetes/prediabetes planning surgery, and healthy volunteers.
Joining could help improve future diabetes treatment for others.

Who may be eligible?

This study is looking for two main groups of people: those planning to have or who have had Roux-en-Y gastric bypass surgery for type 2 diabetes or prediabetes, and healthy volunteers to compare against.

If you're considering the surgery group, you should be between 18 and 80 years old, have type 2 diabetes or prediabetes, have been a stable weight for at least three months, and be considered obese (BMI of 30 or more). You must also meet the NHS guidelines (NICE 2014 criteria) for weight-loss surgery. It's important that you don't smoke, haven't been pregnant recently, and are able to understand English.

For the healthy volunteer group, you should also be between 18 and 80, have a healthy body weight (BMI between 19 and 25), and a stable weight for at least three months. You should not have diabetes or any other medical conditions that could interfere with the study. Similar to the surgery group, you shouldn't smoke, be pregnant or breastfeeding, or have donated blood recently.

Quick self-check

Are you between 18 and 80 years old?
Do you have type 2 diabetes or prediabetes AND are you planning Roux-en-Y gastric bypass surgery?
OR are you a healthy adult with a normal BMI?
Have you been a stable weight for at least 3 months?
Are you able to speak and understand English?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The detailed involvement for participants isn't provided in the brief summary, but from the type of information explored (fat distribution, genetic markers, gut hormone responses), it will likely involve several visits to a clinic. These visits could include physical examinations, blood tests (to check genetic markers and hormone levels, possibly after a meal), and possibly body scans like DEXA to measure body fat. The study mentions 'gut hormone responses to a mixed meal', suggesting you might be asked to eat a specific meal and then have blood samples taken over a period of time. You would also need to be able to provide informed consent and communicate in English. The total duration of participation and frequency of visits are not specified, but this type of research often involves follow-up over several months.

Potential risks and benefits

Taking part in a study like this might offer a chance to contribute to scientific understanding, potentially helping others with type 2 diabetes in the future. While there are no direct medical recommendations, understanding more about your own health could be an indirect benefit. Potential risks might include the discomfort associated with blood tests or specific dietary challenges during assessments. As with any study, you are free to withdraw your consent and stop participating at any time without needing to give a reason, and this will not affect your medical care.

Locations (1)

Imperial College Healthcare NHS Trust
London, United Kingdom· Recruiting

Common questions

What is Roux-en-Y gastric bypass surgery?

It's a type of weight-loss surgery where a small pouch is created from the stomach and connected directly to a lower part of the small intestine, bypassing most of the stomach and the first part of the small intestine.

What does 'diabetes remission' mean?

It means your blood sugar levels are back to normal range without needing diabetes medication, often after a significant intervention like weight-loss surgery.

What is a 'BMI'?

BMI stands for Body Mass Index. It's a measure that uses your height and weight to work out if your weight is healthy.

Are there any costs involved for me?

Clinical trials generally do not charge participants for taking part. Any tests or procedures related to the study are usually covered by the research organisers.

What if I get pregnant during the study?

If you are in the surgery group, pregnancy would likely mean you can't continue in the study. If you are a healthy volunteer, you must not be pregnant or breastfeeding to take part.

How to find out more

Julia S Kenkre, MB BChir

imperial.bariatricstudy@nhs.net +44208383242 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.