RecruitingNAINTERVENTIONAL

Gut Hormones and Roux en Y Gastric Bypass

This study aims to understand why Roux-en-Y gastric bypass surgery helps people with obesity and type 2 diabetes. We know that this surgery changes certain natural chemicals in the gut, called 'gut hormones'. The main goal is to find out if these hormone changes are responsible for some of the good effects seen after surgery. These good effects include better blood sugar control, burning more energy, eating less, losing weight, and being less interested in unhealthy foods. By understanding this, we hope to find new ways to help people in the future, without needing surgery for everyone. We'll be comparing surgery to diet, and also giving some participants hormone-like substances or a dummy treatment (placebo) to see their effects.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

190

Start

01 Oct 2013

Estimated completion

31 Oct 2028

Obesity Type 2 Diabetes

What is this study about?

This research study is looking into a type of weight-loss surgery called Roux-en-Y gastric bypass. Many people who have this surgery find it not only helps them lose weight but also improves their type 2 diabetes. We know that after this surgery, the body produces different amounts of natural chemicals called 'gut hormones'. We believe these changes might be a key reason why the surgery works so well.

The main aim of this study is to see if these changes in gut hormones are directly responsible for the good things that happen after gastric bypass surgery. For example, do they help control blood sugar better, make your body burn more energy, or naturally reduce how much you want to eat? We also want to see if they change how your brain reacts to tempting foods, making you less interested in high-calorie options.

By carefully studying these natural body chemicals, we hope to learn more about how our bodies control weight and blood sugar. This knowledge could help us develop new treatments in the future for obesity and type 2 diabetes that might not always involve surgery, or to make existing treatments even better.

Key takeaways

This study aims to understand why weight-loss surgery helps with obesity and type 2 diabetes.
It focuses on how natural body chemicals (gut hormones) might cause these improvements.
Participants may receive surgery, gut hormone-like infusions, a dummy treatment, or a very low-calorie diet.
The research hopes to find better ways to help people with these conditions in the future.
Eligibility includes specific age, health conditions, and current diabetes management.

Who may be eligible?

You might be able to take part in this study if you are aged between 18 and 70 years old, male or female. You would need to be considered eligible for weight-loss surgery by the NHS due to your weight. You also need to have been diagnosed with pre-diabetes (impaired glucose regulation) or type 2 diabetes. If you have diabetes, it needs to be stable and well-managed, either through diet or with only one type of oral (tablet) medication, and your blood sugar control needs to be below a certain level.

There are several reasons why you might not be able to join. For instance, if you have any serious long-term health conditions, mental health issues, or take certain medications that the study doctors feel could interfere with the research or put you at risk. We also can't include pregnant or breastfeeding individuals, smokers, or those undergoing insulin treatment for diabetes. If you have claustrophobia or certain metal implants that would stop you from having an MRI scan, you also wouldn't be able to participate. This is to ensure everyone in the study can take part safely and that the results are reliable.

The study also cannot accept you if you've already had weight-loss surgery in the past, or if you can't be reached by phone. If you've recently donated blood or plan to, or if you're unable to use reliable contraception during and shortly after the study, you also won't be able to take part. This ensures consistency and safety for everyone involved.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you have type 2 diabetes or pre-diabetes, managed without insulin?
Are you eligible for weight-loss surgery under NHS guidelines?
Are you a non-smoker?
Are you not pregnant or breastfeeding, and can use contraception during the study?
Do you not have a history of serious heart problems, or other conditions that would make taking part unsafe?

Answer every question to see your result.

What does participation involve?

Unfortunately, the detailed description of what taking part involves, such as the number of visits, specific assessments, medication details, or the overall duration of the study, was not provided in the original text. You would need to ask the study team for this information if you were interested in joining.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as gaining a better understanding of your own health and possibly contributing to new treatments for obesity and type 2 diabetes. However, there may also be potential risks associated with the procedures involved, such as receiving infusions or undergoing a very low-calorie diet, which would be fully explained to you before you agree to participate. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

NIHR/Wellcome Trust Imperial CRF, Hammersmith Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are 'gut hormones'?

Gut hormones are natural chemicals made by your body, mainly in your stomach and gut, that help control things like how hungry you feel, how your body uses energy, and how it handles sugar.

What is Roux-en-Y Gastric Bypass surgery?

This is a type of weight-loss surgery where a small pouch is made from your stomach and directly connected to a lower part of your small intestine. This changes how your body digests food.

Why are you looking at a very low-calorie diet?

A very low-calorie diet is another way to help with weight loss and diabetes. We might compare its effects to surgery and hormone treatments to understand different ways of improving health.

Will I definitely get the surgery in this study?

The study mentions 'Roux en Y Gastric Bypass Surgery' as an intervention. You would need to ask the study team if it's an option for you within the study or if it's being studied in people who have already had it.

What is a 'placebo infusion'?

A placebo infusion is like a dummy treatment. It's given in the same way as the active treatment (like the hormone infusion), but it doesn't contain any active medicine. This helps researchers see if any effects are due to the actual treatment or other factors.

How to find out more

Tricia Tan, MBChB MRCP

t.tan@imperial.ac.uk Official trial record

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