Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
The Research Institute of the McGill University Health Centre
TERMINATED
Montreal
Centre de recherche de l'IUCPQ
RECRUITING
Québec
Centre de recherche du CHU de Québec - Université Laval
ACTIVE_NOT_RECRUITING
Québec
Contact Information
Primary
Sarah Chouinard-Castonguay
Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca
4185254444
Time Frame
Start Date: 2018-03-15
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 100
Treatments
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
Sponsors
Leads: CHU de Quebec-Universite Laval
Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre

This content was sourced from clinicaltrials.gov