RecruitingOBSERVATIONAL

Bone and Muscle Health Following Sleeve Gastrectomy in Men, Premenopausal and Postmenopausal Women

This study aims to understand how a type of weight loss surgery called sleeve gastrectomy affects your bones and muscles. While weight loss surgery is helpful for health, some older types were linked to weaker bones and more falls. Sleeve gastrectomy is now very common, and this study wants to see if it also causes changes in bone and muscle, even though it doesn't cause problems with absorbing nutrients. Researchers will compare bone density and muscle size in men, women before menopause, and women after menopause who have this surgery, with people who haven't had the surgery, over three years. This will help us learn more about keeping bones and muscles strong after surgery.

At a glance

Status

Recruiting

Sponsor

CHU de Quebec-Universite Laval

Enrolment target

156

Start

14 Sep 2022

Estimated completion

15 Aug 2026

Bariatric Surgery Bone Health Severe Obesity Muscle Health

What is this study about?

Sleeve gastrectomy is a common operation that helps people lose a lot of weight. While we know that losing weight can make you much healthier overall, doctors are still trying to understand all the ways this surgery affects the body in the long term.

Older types of weight loss surgery sometimes led to problems like weaker bones and an increased risk of falls several years after the operation. Sleeve gastrectomy is different because it doesn't cause the same issues with absorbing food nutrients. However, doctors believe that the big weight loss itself, and other changes in the body after surgery, might still affect your bones and muscles.

This study wants to find out exactly what happens to your bones and muscles after sleeve gastrectomy. Researchers will measure bone strength in your spine and muscle size in your leg over three years. They will compare these measurements in men, women who haven't gone through menopause, and women who have gone through menopause, both in people who have had the surgery and those who haven't. This important research will help us provide better advice and care for people who have this surgery, making sure they stay as healthy as possible.

Key takeaways

The study looks at bone and muscle health after sleeve gastrectomy.
It compares people who have the surgery with those who don't.
Researchers will track changes over three years in different groups (men, pre- and post-menopausal women).
It doesn't involve new medications, only observations and scans.
The goal is to provide better long-term care for people having weight loss surgery.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. You could be considering or planning to have sleeve gastrectomy surgery, or you might be someone who meets the health requirements for the surgery but hasn't decided to have it.

Both men and women can participate. For women, the study will also look at whether you have gone through menopause (meaning you haven't had a period for a year and have specific hormone levels), or if you are still having periods, even if you are using birth control pills or hormone replacement.

You might still be able to join if you have Type 2 diabetes. However, you can't participate if you have Type 1 diabetes, certain uncontrolled health conditions that affect your body's ability to absorb nutrients or cause inflammation, kidney issues, or if you're taking medicines that significantly affect bone health. If you are pregnant, planning to become pregnant, or breastfeeding, you cannot join this study. Also, there are weight limits for some of the scans, so if you weigh more than 204 kg or have a very high BMI, you might not be able to take part.

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 considering or planning sleeve gastrectomy, or meet the health requirements for it?
Do you have Type 1 diabetes, uncontrolled thyroid issues, or certain kidney problems?
Are you pregnant, planning to be, or breastfeeding?
Are you within the weight limits for medical scans (generally under 204 kg)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have several visits over a three-year period. During these visits, you will undergo various assessments to measure your bone strength and muscle size. This will involve different types of scans, including special X-rays (like DXA scans, which measure bone density) and CT scans (which provide detailed pictures of your bones and muscles). You might also have some tests to check your physical fitness and strength, like simple exercises, to see how well your muscles are working. The study is comparing people who have sleeve gastrectomy with those who don't, so your participation will involve these assessments whether you have the surgery or not. You won't be given any new medication as part of this study. The total duration of your involvement will be three years.

Potential risks and benefits

Taking part in this study may not directly benefit you, but the information found will help doctors better understand how sleeve gastrectomy affects bone and muscle health for future patients. Risks are generally low and involve the minor radiation exposure from the scans, which is kept as low as possible, and the time commitment for appointments. All procedures will be carefully explained to you beforehand. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre de recherche de l'IUCPQ
Verified postcode
Québec, Canada· Recruiting

Common questions

What is sleeve gastrectomy?

It's a type of weight loss surgery where a large part of the stomach is removed, making it much smaller. This helps people eat less and feel full sooner.

Why are you studying bones and muscles after this surgery?

Even though sleeve gastrectomy helps with weight loss, we want to make sure we understand all its effects on the body, including how it changes bone strength and muscle over time.

Will I have to take any new medicines in this study?

No, this study is observing changes, not testing new medications. You will continue with any medication your own doctor has prescribed for you.

What kind of tests will I have?

You'll have scans like special X-rays (DXA) and CT scans to measure your bone density and muscle size, along with some simple physical strength tests.

How long will I be in the study?

If you join, you will be part of the study for three years, with regular check-ups during that time.

How to find out more

Sandrine Hegg-Deloye, PhD

sandrine.hegg-deloye@crchudequebec.ulaval.ca 4185254444 Official trial record

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