Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

CHU de Quebec-Universite Laval100 enrolled

Overview

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.

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

100

Conditions

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

Interventions

Bariatric surgeryPROCEDURE

Sleeve gastrectomy

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (3)

The Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

TERMINATED

Centre de recherche du CHU de Québec - Université Laval

Québec, Quebec, Canada

ACTIVE_NOT_RECRUITING

Centre de recherche de l'IUCPQ

Québec, Quebec, Canada

RECRUITING

Outcomes

Primary Outcomes

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

assessed by quantitative computed tomography (QCT)

Time frame: 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)

Time frame: before, 1 year after and 3 years after bariatric surgery

Secondary Outcomes

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

serum bone formation marker

Time frame: 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

Time frame: 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

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

Change in C-telopeptide

serum bone resorption marker

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

Change in fasting glucose

diabetes control

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

Change in HbA1c

diabetes control

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

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

Change in sclerostin

hormones involved in bone metabolism

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

Change in adiponectin

hormones involved in bone metabolism

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

Change in leptin

hormones involved in bone metabolism

Time frame: 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

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

Change in ghrelin

hormones involved in bone metabolism

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in visceral and subcutaneous adipose tissue

body composition assessed by computed tomography (CT)

Time frame: 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)

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in upper extremity muscle strength

assessed by hand grip strength

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in lower extremity muscle strength

assessed by knee extensor strength

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in muscle function

assessed by timed up and go test

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in physical capacity

assessed by 6-minute walk test

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in balance

assessed by Fullerton Advanced Balance (FAB) Scale

Time frame: before and 1 year after bariatric surgery

Change in sociodemographic factors

questionnaire

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in nutrition

3 web-based 24-h recalls

Time frame: 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

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

Change in measured physical activity level

by accelerometer

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in gut microbiota

stool sample

Time frame: before, 1 year after and 3 years after bariatric surgery

Change in cutaneous Advanced glycation end products (AGEs)

skin autofluorescence

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

Central Contacts

Sarah Chouinard-Castonguay

CONTACT

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

Data from ClinicalTrials.gov

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