Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

NCT03455868 | Recruiting

• 1 other identifier: MP-10-2018-2957
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (2)

• Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius

  assessed by quantitative computed tomography (QCT)

  before, 1 year after and 3 years after bariatric surgery

• Change in areal bone mineral density at lumbar spine, hip and radius

  assessed by dual-energy X-ray absorptiometry (DXA)

  before, 1 year after and 3 years after bariatric surgery

Secondary Outcomes (33)

• Change in N-terminal propeptide of type 1 procollagen (P1NP)

  before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

• Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated)

  before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

• Change in bone alkaline phosphatase

  before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

• Change in C-telopeptide

  before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

• Change in fasting glucose

  before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

Other Outcomes (4)

• Bone microarchitecture and metabolism

  during surgery

• Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5)

  before, 1 year after and 3 years after bariatric surgery

• Prevalence and incidence of falls

  before, 1 year after and 3 years after bariatric surgery

Study Arms (2)

Sleeve gastrectomy diabetes

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

Procedure: Bariatric surgery

Control without obesity or diabetes

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

Interventions

Bariatric surgery PROCEDURE

Sleeve gastrectomy

Sleeve gastrectomy diabetes

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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). 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (3)

The Research Institute of the McGill University Health Centre

Montreal, Quebec, H3H 2R9, Canada

TERMINATED

Centre de recherche du CHU de Québec - Université Laval

Québec, Quebec, G1V 4G2, Canada

ACTIVE NOT RECRUITING

Centre de recherche de l'IUCPQ

Québec, Quebec, G1V 4G5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood (serum and plasma)

MeSH Terms

Conditions

Obesity, Morbid; Diabetes Mellitus, Type 2

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Claudia Gagnon, Dr

  CHU de Québec - Université Laval

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Chouinard-Castonguay

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: March 7, 2018
• Study Start: March 15, 2018
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)