Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

— BODI  

Official title:

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03455868
• Other study ID #: MP-10-2018-2957
• Status: Recruiting
• Start date: March 15, 2018
• Est. completion date: December 1, 2025

Study information

• Verified date: February 2024
• Source: CHU de Quebec-Universite Laval
• Contact: Sarah Chouinard-Castonguay
• Phone: 4185254444
• Email: Sarah.Chouinard-Castonguay[@]crchudequebec.ulaval.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Bone Health
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obesity, Morbid

Intervention

Procedure:
• Bariatric surgery
Sleeve gastrectomy

Locations

Country	Name	City	State
Canada	The Research Institute of the McGill University Health Centre	Montréal	Quebec
Canada	Centre de recherche du CHU de Québec - Université Laval	Quebec
Canada	Centre de recherche de l'IUCPQ	Québec

Sponsors (2)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval	McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bone microarchitecture and metabolism	by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry	during surgery
Other	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
Other	Prevalence and incidence of falls	by questionnaire	before, 1 year after and 3 years after bariatric surgery
Other	Prevalence and incidence of non-vertebral fractures	by questionnaire (self-reported)	before, 1 year after and 3 years after bariatric surgery
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Change in C-telopeptide	serum bone resorption marker	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Secondary	Change in fasting glucose	diabetes control	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Secondary	Change in HbA1c	diabetes control	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in sclerostin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Secondary	Change in adiponectin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Secondary	Change in leptin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Secondary	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
Secondary	Change in ghrelin	hormones involved in bone metabolism	before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	Change in fat and lean mass	body composition assessed by bioimpedance and by DXA	before, 1 year after and 3 years after bariatric surgery
Secondary	Change in visceral and subcutaneous adipose tissue	body composition assessed by computed tomography (CT)	before, 1 year after and 3 years after bariatric surgery
Secondary	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
Secondary	Change in upper extremity muscle strength	assessed by hand grip strength	before, 1 year after and 3 years after bariatric surgery
Secondary	Change in lower extremity muscle strength	assessed by knee extensor strength	before, 1 year after and 3 years after bariatric surgery
Secondary	Change in muscle function	assessed by timed up and go test	before, 1 year after and 3 years after bariatric surgery
Secondary	Change in physical capacity	assessed by 6-minute walk test	before, 1 year after and 3 years after bariatric surgery
Secondary	Change in balance	assessed by Fullerton Advanced Balance (FAB) Scale	before and 1 year after bariatric surgery
Secondary	Change in sociodemographic factors	questionnaire	before, 1 year after and 3 years after bariatric surgery
Secondary	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
Secondary	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
Secondary	Change in measured physical activity level	by accelerometer	before, 1 year after and 3 years after bariatric surgery
Secondary	Change in gut microbiota	stool sample	before, 1 year after and 3 years after bariatric surgery
Secondary	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