Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorCHU de Quebec-Universite Laval
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bariatric surgery
Procedure/SurgerySleeve gastrectomy
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Sleeve gastrectomy diabetes1 intervention
Group B: Control without obesity or diabetes0 interventions
Trial outcomes
Primary outcomes
1
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 surgery2
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 surgerySecondary outcomes
1
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 surgery2
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 surgery3
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 surgery4
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 surgeryOther outcomes
1
Bone microarchitecture and metabolism
by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry
Time frame
during surgery2
Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5)
Using the algorithm-based qualitative method (ABQ) and the Genant method
Time frame
before, 1 year after and 3 years after bariatric surgery3
Prevalence and incidence of falls
by questionnaire
Time frame
before, 1 year after and 3 years after bariatric surgery4
Prevalence and incidence of non-vertebral fractures
by questionnaire (self-reported)
Time frame
before, 1 year after and 3 years after bariatric surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
CHU de Quebec-Universite Laval
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborator
Source ClinicalTrials.gov