Recruiting

Observational Study

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT03455868

Conditions

Bariatric Surgery

Bone Health

Obesity, Morbid

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Bariatric surgery

Study Details

Brief 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.

Conditions

Bariatric Surgery

Bone Health

Obesity, Morbid

Diabetes Mellitus, Type 2

Study ID

NCT03455868

Start date

Mar 15, 2018

Status verified date

Jun, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Sleeve gastrectomy diabetes

70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy

Control without obesity or diabetes

30 Men and women who are overweight (without obesity) and without diabetes

Interventions

Bariatric surgery

Sleeve gastrectomy

Primary outcome measure

  • Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius [ Time Frame: before, 1 year after and 3 years after bariatric surgery ]
  • Change in areal bone mineral density at lumbar spine, hip and radius [ Time Frame: before, 1 year after and 3 years after bariatric surgery ]

Central Contacts and Locations

Central contacts

Sarah Chouinard-Castonguay

4185254444Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca

Locations

Centre de recherche de l'IUCPQ

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

Sarah Chouinard-Castonguay

4185254444Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca

Principal Investigator:

Gagnon Claudia, Dr

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2025-06-10.