RecruitingOBSERVATIONAL

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

This research is looking into how a common type of weight-loss surgery, called sleeve gastrectomy, affects bone health in people who have Type 2 diabetes. We know that diabetes can sometimes make bones fragile, and treatments for diabetes might either help or harm bone strength. As weight-loss surgery becomes more popular for people with Type 2 diabetes, it's important to understand its impact on their bones. The main goal is to check bone strength in people with Type 2 diabetes having this surgery. We also want to find out what factors might influence bone health after surgery and compare these results to people who are overweight but don't have diabetes, and also to healthy individuals who are not overweight and don't have diabetes.

At a glance

Status

Recruiting

Sponsor

CHU de Quebec-Universite Laval

Enrolment target

100

Start

15 Mar 2018

Estimated completion

01 Dec 2025

Bariatric Surgery Bone Health Obesity, Morbid Diabetes Mellitus, Type 2

What is this study about?

This study is designed to help us understand how a specific type of weight-loss surgery, called sleeve gastrectomy, influences bone health. We're particularly interested in people who also have Type 2 diabetes. You might wonder why this is important. Well, people with Type 2 diabetes can sometimes have weaker bones and be more prone to fractures, and some diabetes treatments can affect bone strength.

Weight-loss surgery is becoming a more common treatment for people with Type 2 diabetes, often leading to significant improvements in their health. However, we need to make sure we understand all the effects, including how it impacts bones. This study will take pictures of bones using special scans, like a 3D X-ray, to see how bone strength changes over time after the surgery. We'll also look at other factors like diet, activity, and medication.

By carefully studying these changes, we hope to gain a clearer picture of how sleeve gastrectomy affects bone health in people with Type 2 diabetes. This knowledge can help doctors provide the best advice and care for their patients, ensuring they stay as healthy as possible both before and after surgery.

Key takeaways

Looks at how weight-loss surgery affects bone health in people with Type 2 diabetes.
Compares surgical patients to healthy individuals without diabetes or obesity.
Involves special bone scans (QCT) before and after surgery.
Aims to improve care for people with Type 2 diabetes having bariatric surgery.
Participation includes regular check-ups for up to three years for surgery patients.

Who may be eligible?

This study is looking for adults, both men and women, between 18 and 60 years old. If you're considering sleeve gastrectomy surgery, you might be able to take part if you have a BMI (Body Mass Index) of 35 or higher and have Type 2 diabetes, or if you're awaiting this surgery without diabetes but still have a high BMI.

We also need a group of healthy volunteers for comparison. These are men and women who are overweight (BMI between 25 and 29.9), are not diabetic or pre-diabetic, and have had a stable weight for the past three months.

You wouldn't be able to join the study if you have Type 1 diabetes, certain health conditions that affect bones (like severe kidney disease or an overactive thyroid), or if you're taking medications that strongly impact bone health (like certain steroids or osteoporosis treatments). Also, if you're pregnant, planning to become pregnant during the study, or have had previous stomach or weight-loss surgery, you wouldn't be eligible. For the comparison group, pregnant or breastfeeding women in the last year, or those with significant recent weight changes, would also not be eligible.

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 60 years old?
Are you awaiting sleeve gastrectomy surgery for obesity with or without Type 2 diabetes?
Do you have a BMI of 35 or higher (if in the surgery group)?
Do you not have other serious health problems affecting your bones or Type 1 diabetes?
Are you not pregnant or planning to be during the study?
If you're interested in the comparison group, are you overweight (BMI 25-29.9), not diabetic, and haven't had recent major weight changes?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll be part of a group either undergoing sleeve gastrectomy surgery or acting as a comparison. If you're in the surgery group, you'll have some assessments before your operation and then at around 4 months, 8 months, 1 year, and 3 years after surgery. These assessments will involve special bone scans using a method called QCT, which is like a very detailed X-ray, and likely blood tests and questionnaires.

If you're in the comparison group, you will have just one visit where you'll undergo similar assessments, including the bone scan, blood tests, and answer some questions. The QCT scans help us look at your bone strength in 3D. The overall duration of your involvement will depend on which group you are in, ranging from a single visit for the control group to three years for the surgery group. No new medications will be given as part of this study.

Potential risks and benefits

Taking part in this study could offer some benefits, such as gaining a better understanding of your own bone health. While it won't directly change your treatment plan, the information gathered will help the wider medical community provide better care for people having weight-loss surgery, especially those with diabetes. There are some potential risks associated with the study, mainly from the radiation exposure during the QCT bone scans. This exposure is small, similar to what you'd get on a long-haul flight, but it's important to be aware of it. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

The Research Institute of the McGill University Health Centre
Verified postcode
Montreal, Canada· Terminated
Centre de recherche du CHU de Québec - Université Laval
Verified postcode
Québec, Canada· Active not recruiting
Centre de recherche de l'IUCPQ
Verified postcode
Québec, Canada· Recruiting

Common questions

What is sleeve gastrectomy?

Sleeve gastrectomy is a type of weight-loss surgery where a large part of the stomach is removed, leaving a smaller, banana-shaped stomach. This helps people eat less and feel full sooner.

What is QCT and is it safe?

QCT is a special type of X-ray scan that creates 3D pictures of your bones, helping doctors measure their strength more accurately. It uses a small amount of radiation, similar to everyday exposure, and is considered safe for research purposes.

Will this study change my diabetes treatment?

No, this study is observational, meaning we just gather information. It will not change any of your current diabetes treatments or care plans. All medical decisions will remain with your regular doctor.

What does 'bone fragility' mean?

Bone fragility means that your bones are weaker than they should be, making them more likely to break or fracture even from minor falls or stresses.

Do I need to pay to be in this study?

No, you will not have to pay to take part in this study. All study-related tests and visits are covered by the research program.

How to find out more

Sarah Chouinard-Castonguay

sarah.chouinard-castonguay@crchudequebec.ulaval.ca 4185254444 Official trial record

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