Clinical trial NCT03455868: Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Official title: Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bariatric Surgery
Bone Health
Obesity, Morbid
Diabetes Mellitus, Type 2
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted: 2018-03-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in areal bone mineral density at lumbar spine, hip and radius
timeFrame: before, 1 year after and 3 years after bariatric surgery
Secondary outcomes:
measure: Change in N-terminal propeptide of type 1 procollagen (P1NP)
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated)
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in bone alkaline phosphatase
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in C-telopeptide
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in fasting glucose
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in HbA1c
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in fasting insulin
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in serum 25-hydroxyvitamin D
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in parathormone (PTH)
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in estradiol and estrone
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in insulin like growth factor (IGF)-1
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in sclerostin
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in adiponectin
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in leptin
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in peptide YY (PYY)
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in ghrelin
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in oxidative stress markers
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in serum advanced glycation end products (AGEs)
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in Free fatty acids (FFA)
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in fat and lean mass
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in visceral and subcutaneous adipose tissue
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in muscle mass and fat content at mid-femur
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in upper extremity muscle strength
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in lower extremity muscle strength
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in muscle function
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in physical capacity
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in balance
timeFrame: before and 1 year after bariatric surgery
measure: Change in sociodemographic factors
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in nutrition
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in self-reported physical activity level
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
measure: Change in measured physical activity level
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in gut microbiota
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Change in cutaneous Advanced glycation end products (AGEs)
timeFrame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Other outcomes:
measure: Bone microarchitecture and metabolism
timeFrame: during surgery
measure: Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5)
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Prevalence and incidence of falls
timeFrame: before, 1 year after and 3 years after bariatric surgery
measure: Prevalence and incidence of non-vertebral fractures
timeFrame: before, 1 year after and 3 years after bariatric surgery
Locations:
city: Montréal
country: Canada
facility: The Research Institute of the McGill University Health Centre
state: Quebec
city: Québec
country: Canada
facility: Centre de recherche de l'IUCPQ
state: Quebec
city: Quebec
country: Canada
facility: Centre de recherche du CHU de Québec - Université Laval
Study officials:
affiliation: CHU de Québec - Université Laval
name: Claudia Gagnon, Dr
role: PRINCIPAL_INVESTIGATOR
References: