Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes (BODI)

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Obesity, Morbid; Bariatric Surgery; Bone Health
• Intervention / Treatment: Procedure: Bariatric surgery

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Sarah Chouinard-Castonguay; Phone Number: 48729 4185254444; Email: Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca

Study Locations

• Canada
  • Quebec, Canada, G1V 4G2
    • Active, not recruiting
    • Centre de recherche du CHU de Québec - Université Laval
  • Québec, Canada, G1V 4G5
    • Recruiting
    • Centre de recherche de l'IUCPQ
    • Contact: Sarah Chouinard-Castonguay; Phone Number: 48729 4185254444; Email: Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca
    • Principal Investigator: Gagnon Claudia, Dr
  • Quebec
    • Montréal, Quebec, Canada, H3H 2R9
      • Terminated
      • The Research Institute of the McGill University Health Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Sleeve gastrectomy diabetes; 70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy	Procedure: Bariatric surgery; Sleeve gastrectomy
Control without obesity or diabetes; 30 Men and women who are overweight (without obesity) and without diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in N-terminal propeptide of type 1 procollagen (P1NP)	serum bone formation marker	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)	serum bone formation marker	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in bone alkaline phosphatase	serum bone formation marker	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in C-telopeptide	serum bone resorption marker	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in fasting glucose	diabetes control	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in HbA1c	diabetes control	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in fasting insulin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in serum 25-hydroxyvitamin D	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in parathormone (PTH)	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in estradiol and estrone	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in insulin like growth factor (IGF)-1	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in sclerostin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in adiponectin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in leptin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in peptide YY (PYY)	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in ghrelin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in oxidative stress markers	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in serum advanced glycation end products (AGEs)	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in Free fatty acids (FFA)	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in fat and lean mass	body composition assessed by bioimpedance and by DXA	before, 1 year after and 3 years after bariatric surgery
Change in visceral and subcutaneous adipose tissue	body composition assessed by computed tomography (CT)	before, 1 year after and 3 years after bariatric surgery
Change in muscle mass and fat content at mid-femur	assessed by computed tomography (CT)	before, 1 year after and 3 years after bariatric surgery
Change in upper extremity muscle strength	assessed by hand grip strength	before, 1 year after and 3 years after bariatric surgery
Change in lower extremity muscle strength	assessed by knee extensor strength	before, 1 year after and 3 years after bariatric surgery
Change in muscle function	assessed by timed up and go test	before, 1 year after and 3 years after bariatric surgery
Change in physical capacity	assessed by 6-minute walk test	before, 1 year after and 3 years after bariatric surgery
Change in balance	assessed by Fullerton Advanced Balance (FAB) Scale	before and 1 year after bariatric surgery
Change in sociodemographic factors	questionnaire	before, 1 year after and 3 years after bariatric surgery
Change in nutrition	3 web-based 24-h recalls	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in self-reported physical activity level	by questionnaire	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in measured physical activity level	by accelerometer	before, 1 year after and 3 years after bariatric surgery
Change in gut microbiota	stool sample	before, 1 year after and 3 years after bariatric surgery
Change in cutaneous Advanced glycation end products (AGEs)	skin autofluorescence	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone microarchitecture and metabolism	by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry	during surgery
Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5)	Using the algorithm-based qualitative method (ABQ) and the Genant method	before, 1 year after and 3 years after bariatric surgery
Prevalence and incidence of falls	by questionnaire	before, 1 year after and 3 years after bariatric surgery
Prevalence and incidence of non-vertebral fractures	by questionnaire (self-reported)	before, 1 year after and 3 years after bariatric surgery

Collaborators and Investigators

• Sponsor: CHU de Quebec-Universite Laval
• Collaborators: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Investigators: Principal Investigator: Claudia Gagnon, Dr, CHU de Québec - Université Laval

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2018
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: March 5, 2018
• First Posted (Actual): March 7, 2018

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
• Other Study ID Numbers: MP-10-2018-2957

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No