Actively Recruiting

Age: 18Years - 60Years
All Genders
Healthy Volunteers
NCT03455868

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Led by CHU de Quebec-Universite Laval · Updated on 2025-06-10

100

Participants Needed

3

Research Sites

402 weeks

Total Duration

On this page

Sponsors

C

CHU de Quebec-Universite Laval

Lead Sponsor

M

McGill University Health Centre/Research Institute of the McGill University Health Centre

Collaborating Sponsor

AI-Summary

What this Trial Is About

Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in popularity in people with type 2 diabetes and may impact bone health. Objectives: To evaluate the impact of the most popular bariatric procedure worldwide (sleeve gastrectomy (SG)) on vBMD by QCT in patients with type 2 diabetes; Secondary aims: (1) to identify the determinants of vBMD after bariatric surgery in patients with type 2 diabetes; (2) to compare vBMD and its potential determinants after bariatric surgery with obese controls without diabetes as well as with controls without obesity and normoglycemia.

CONDITIONS

Official Title

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women aged 18 to 60 years
  • For bariatric groups: BMI of 35 kg/m2 or higher
  • For type 2 diabetes patients: use of oral hypoglycemic agents or insulin, or diagnosis confirmed by two tests (HbA1c ≥6.5%, fasting glucose ≥7.0 mM, or 2-hour glucose post-OGTT ≥11.1 mM)
  • For bariatric group without diabetes: HbA1c below 6.5% and fasting glucose below 7.0 mM
  • Control group: BMI between 25.0 and 29.9 kg/m2, no diabetes or prediabetes, stable weight for last 3 months
Not Eligible

You will not qualify if you...

  • Type 1 diabetes
  • Diseases affecting bone metabolism such as uncontrolled thyroid disease, malabsorptive or inflammatory disorders, metabolic bone disease
  • Medications affecting bone metabolism, including glucocorticoids, anti-epileptic drugs, osteoporosis therapy, thiazolidinediones
  • BMI over 60 kg/m2
  • Inability to perform CT scan due to size
  • Pregnancy or planning pregnancy during study, or women of childbearing age not agreeing to contraception
  • History of oesophageal, gastric, or digestive surgery
  • Previous bariatric surgery
  • Cancer with risk of recurrence during study
  • Prosthesis interfering with imaging
  • Severe chronic illness preventing participation
  • For control group: more than 5% weight change in last 3 months, pregnancy or lactation in past year

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada, H3H 2R9

Terminated

2

Centre de recherche du CHU de Québec - Université Laval

Québec, Quebec, Canada, G1V 4G2

Active, Not Recruiting

3

Centre de recherche de l'IUCPQ

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

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Research Team

S

Sarah Chouinard-Castonguay

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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