RecruitingObservational

How is glucose variability changed among people having metabolic surgery, and how does this affect pregnancy and its outcomes?

This research explores how blood sugar levels change after weight-loss surgery, sometimes called metabolic surgery. After these operations, some people experience big swings in their blood sugar, where it goes very high then very low. This study wants to see if different types of surgery lead to these blood sugar swings. It also looks at how these changes might affect women who become pregnant after surgery. We know that some women who have had certain weight-loss surgeries can have problems during pregnancy, like babies being born smaller or earlier. This study hopes to find out if these blood sugar swings play a role, and if these issues also happen with other types of weight-loss surgery. The goal is to help us better understand and support people undergoing these surgeries, especially during pregnancy.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

1,254

Start

01 Apr 2022

Estimated completion

01 Jun 2034

Glucose variability after metabolic surgery

What is this study about?

This study is looking into how your blood sugar levels change after a type of surgery called metabolic surgery, which includes operations like gastric bypass. These surgeries are very effective for treating obesity and diabetes by helping people lose weight and sometimes even reducing or getting rid of their diabetes. However, some people who have these surgeries can experience noticeable ups and downs in their blood sugar, where it might go very high after eating and then drop too low (which is called a hypo). This study aims to understand if these 'swings' in blood sugar, known as glucose variability, are more common with certain types of metabolic surgery than others.

Another important part of this research focuses on women who become pregnant after having metabolic surgery. We know that pregnancy can sometimes be more complicated for women who have had one specific type of these surgeries (called Roux-en-Y Gastric Bypass), with higher chances of babies being born smaller or earlier. It's not clear if these issues are linked to the blood sugar swings we mentioned, or if they also happen with other common types of metabolic surgery, like sleeve gastrectomy or mini gastric bypass. By studying these connections, we hope to learn more about how metabolic surgery affects both a mother's health and her baby's development during and after pregnancy.

The findings from this study will help doctors and patients understand the long-term effects of metabolic surgery, especially in terms of blood sugar control and planning for pregnancy. By gathering this important information, we can work towards providing better support and care for people who have these surgeries, helping them manage their health and have healthier pregnancies in the future.

Key takeaways

This study investigates how blood sugar levels change after weight-loss surgery.
It aims to see if specific surgeries cause different blood sugar swings.
The research will also explore how these changes might affect pregnancy outcomes.
Participants will wear a blood sugar monitor and have health checks.
The findings could lead to improved care for people after weight-loss surgery, especially mothers and babies.
The study runs until 2035 and is supported by Diabetes UK.

Who may be eligible?

This study is split into two main parts. For Study 1, we are looking for men and women who are 18 years or older and are planning to have weight-loss surgery soon. It doesn't matter if you have diabetes, pre-diabetes, or normal blood sugar levels – all are welcome to take part in this initial phase.

For Study 2, we are focusing on women. We are looking for women who have had weight-loss surgery in the past and are either currently pregnant or planning to get pregnant. We will compare these women with a 'control group' – pregnant women who have not had weight-loss surgery, but are similar in terms of age during pregnancy and their weight before pregnancy. This comparison helps us see the specific effects of the surgery.

You wouldn't be able to join if you have any health condition that the research team thinks would make it unsafe for you to take part, or if you can't or don't want to wear a small monitor on your skin (called a CGM) or have had a bad reaction to similar things before.

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 18 years old or older?
Are you planning to have weight-loss surgery soon (for Study 1)?
Have you had weight-loss surgery and are you pregnant or planning to be (for Study 2)?
Are you comfortable wearing a small blood sugar monitor on your skin?
Do you have any conditions that might make it unsafe for you to participate (the researchers will check this)?

Answer every question to see your result.

What does participation involve?

If you join Study 1 (before your surgery), you will have check-ups before your surgery and at different times afterwards. At each check-up, you'll wear a small device called a Continuous Glucose Monitor (CGM) for 10 days. This device gently sits on your skin and regularly measures your blood sugar. You'll also do finger-prick blood sugar checks at the same time. We'll also do health checks, take blood, urine, and stool samples.

If you join Study 2 (for women who are pregnant or planning to be), you'll have similar checks. These would happen before you get pregnant (if you're planning), during each stage of your pregnancy, and then 3 to 6 months after your baby is born. You will also wear the CGM for 10 days and do finger-prick tests at each of these stages. During the second stage of your pregnancy, you'll have a standard sugar level test (called an oral glucose tolerance test), and we'll take a few extra blood samples then. All women in this study will still receive all the usual care from the NHS during their pregnancy.

Potential risks and benefits

You might not directly feel better from being in this study. However, the information we collect is really important. It will help us understand more about how different weight-loss surgeries affect blood sugar levels, and how these changes might impact pregnancies and the health of babies in the future. This understanding could lead to better care for many people. As for risks, you might feel a little discomfort or get a small bruise from blood tests or from having the CGM sensor placed on your skin. You are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

NIHR Imperial Clinical Research Facility
City only
London, United Kingdom
Imperial College Healthcare NHS Trust
City only
London, United Kingdom
Queen Charlotte's and Chelsea Hospital
City only
London, United Kingdom

Common questions

What is 'glucose variability'?

It means how much your blood sugar levels can swing up and down, especially after eating. They might go very high then drop very low.

What is metabolic surgery?

It's a type of weight-loss surgery, like gastric bypass or sleeve gastrectomy, which helps people lose weight and can improve conditions like diabetes.

What is a CGM device?

It's a small sensor you wear on your skin that continuously monitors and records your blood sugar levels throughout the day and night.

How long will the study last if I join?

The study runs until December 2035. If you join, it could involve check-ups over several years, depending on your situation (e.g., if you become pregnant).

Who is paying for this research?

The study is funded by Diabetes UK and the NIHR Biomedical Research Centre.

How to find out more

Rajalakshmi Valaiyapathi

rv1212@ic.ac.uk +44 (0)7712 485272 Official trial record

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