Trials / Recruiting
RecruitingNCT03455868
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- CHU de Quebec-Universite Laval · Academic / Other
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
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.
Detailed description
This is a multicentre, prospective and observational study comprising a bariatric group with or without diabetes undergoing SG (n=70) and one control group (n=30). Outcome measures are assessed before and at 4 months, 8 months, one year and 3 years after surgery in the bariatric groups and at a single visit for the control group. Bariatric groups will include adult men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy and followed at 0, 4 months, 8 months, 1 year and 3 years after surgery, and the control group will consist of 30 overweight individuals (10 men, 10 premenopausal women, 10 menopausal women) and without diabetes or prediabetes and assessed at a single visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Bariatric surgery | Sleeve gastrectomy |
Timeline
- Start date
- 2018-03-15
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2018-03-07
- Last updated
- 2025-06-10
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT03455868. Inclusion in this directory is not an endorsement.