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NCT03455868Recruiting

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Source: ClinicalTrials.gov · Last updated 10 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
100 (estimated)
First submitted
19 Feb 2018
Start date
15 Mar 2018
Primary completion date
1 Dec 2025
Lead sponsor
CHU de Quebec-Universite Laval
NCT number
NCT03455868

What you commit to

  • Study type: Observational
  • Planned participants: 100
  • From 15 Mar 2018 to the primary completion date, 1 Dec 2025
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Lab values

  • bariatric groups: type 1 diabetes; disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance \<60 ml/min) or medication (e.g. glucocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism; BMI\>60 kg/m2; CT scan impossible to perform (e.g. patient too large for the gantry aperture); pregnant women or women who plan to become pregnant during the study or women of childbearing age who do not agree to take an appropriate contraceptive method during the study; history of oesophageal, gastric or digestive surgery; history of bariatric surgery; cancer at risk of recurrence during the study; Prosthesis that could interfere with interpretation of imaging data; Chronic severe condition or illness precluding from participation in the project.
    • Control group: Same criteria plus: \>5% change in weight in the last 3 months; pregnancy or lactation in the last year.

Who the study is looking for

  • bariatric groups: men and women; 18 to 60 years old; with a BMI \>=35 kg/m2; with type 2 diabetes: use of oral hypoglycemic agents or insulin OR 2 of the following tests confirming type 2 diabetes: HbA1c \>=6.5%; fasting glucose \>=7.0 mM; 2-h glucose post 75g oral glucose tolerance test (OGTT) \>=11.1 mM) (guidelines.diabetes.ca);) or without diabetes: HbA1c \<6.5% AND fasting glucose \<7.0 mM; who are awaiting bariatric surgery. Control group: BMI 25.0 to 29.9 kg/m2 (overweight group); without diabetes or prediabetes: HbA1c \<6.0% AND fasting glucose \<6.1 mM (Diabetes Canada criteria), with a stable weight for the last 3 months.

Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Research Institute of the McGill University Health Centre
Coordinator of this site? Confirm its status
MontrealCanadaTerminated
Centre de recherche du CHU de Québec - Université Laval
Coordinator of this site? Confirm its status
QuébecCanadaActive, not recruiting
Centre de recherche de l'IUCPQ
Coordinator of this site? Confirm its status
QuébecCanadaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.