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

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ClinicalTrials.gov Identifier: NCT03455868
Recruitment Status : Recruiting
First Posted : March 7, 2018
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
McGill University Health Center
Information provided by (Responsible Party):
Claudia Gagnon, CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date February 19, 2018
First Posted Date March 7, 2018
Last Update Posted Date April 17, 2018
Actual Study Start Date March 15, 2018
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 5, 2018)
Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, radius, tibia [ Time Frame: before, 1 and 2 years after bariatric surgery ]
assessed by quantitative computed tomography (QCT)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03455868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: April 13, 2018)
  • Change in N-terminal propeptide of type 1 procollagen (P1NP) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker
  • Change in osteocalcin (total and decarboxylated) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker
  • Change in bone alkaline phosphatase [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker
  • Change in C-telopeptide [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone resorption marker
  • Change in fasting glucose [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    diabetes control
  • Change in HbA1c [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    diabetes control
  • Change in fasting insulin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in serum 25-hydroxyvitamin D [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in parathormone (PTH) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in estradiol and estrange [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in insulin like growth factor (IGF)-1 [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in sclerostin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in adiponectin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in leptin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in peptide YY (PYY) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in ghrelin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in fat and lean mass by dual-energy X-ray absorptiometry (DXA) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition
  • Change in visceral and subcutaneous adipose tissue by quantitative computed tomography (QCT) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition
  • Change in bone marrow adiposity by dual-energy quantitative computed tomography (QCT) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition
  • Change in upper extremity muscle strength [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by hand grip strength
  • Change in lower extremity muscle strength [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    knee extensor strength
  • Change in muscle function [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by timed up and go test
  • Change in muscle function [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by Fullerton Advanced Balance (FAB) Scale
  • Change in sociodemographic factors [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    questionnaire
  • Change in nutrition [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    3 web-based 24-h recalls
  • Change in reported physical activity [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by questionnaire
  • Change in measured physical activity [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by accelerometer
  • Change in gut microbiota [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    stool sample
  • Change in menopausal status (Follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
  • Change in cutaneous Advanced glycation end products (AGEs) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    skin autofluorescence
Original Secondary Outcome Measures
 (submitted: March 5, 2018)
  • Change in N-terminal propeptide of type 1 procollagen (P1NP) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker
  • Change in osteocalcin (total and decarboxylated) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker
  • Change in bone alkaline phosphatase [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker
  • Change in C-telopeptide [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone resorption marker
  • Change in fasting glucose [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    diabetes control
  • Change in HbA1c [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    diabetes control
  • Change in fasting insulin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in serum 25-hydroxyvitamin D [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in parathormone (PTH) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in estradiol [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in insulin like growth factor (IGF)-1 [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in sclerostin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in adiponectin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in leptin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in peptide tyrosine tyrosine (PYY) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in ghrelin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism
  • Change in fat and lean mass by dual-energy X-ray absorptiometry (DXA) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition
  • Change in visceral and subcutaneous adipose tissue by quantitative computed tomography (QCT) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition
  • Change in bone marrow adiposity by dual-energy quantitative computed tomography (QCT) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition
  • Change in muscle strength [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by hand grip strength
  • Change in muscle strength [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    knee extensor strength
  • Change in muscle function [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by timed up and go test
  • Change in muscle function [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by Fullerton Advanced Balance (FAB) Scale
  • Change in sociodemographic factors [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    questionnaire
  • Change in nutrition [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    3 web-based 24-h recalls
  • Change in physical activity [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by questionnaire
  • Change in physical activity [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by accelerometer
  • Change in gut microbiota [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    stool sample
  • Change in menopausal status (Follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
  • Change in cutaneous Advanced glycation end products (AGEs) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    skin autofluorescence
Current Other Outcome Measures Not Provided
Original Other Outcome Measures Not Provided
 
Descriptive Information
Brief Title Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Official Title Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
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 determine, in people with type 2 diabetes and obesity undergoing bariatric surgery: (1) the impact of 3 bariatric procedures namely sleeve gastrectomy, Roux-in-Y gastric bypass and biliopancreatic diversion, on bone fragility; (2) what factors influence bone fragility after bariatric surgery.

Research project overview: This study will involve 3 research centres in the province of Quebec. It will include 105 patients with type 2 diabetes who are undergoing bariatric surgery (35 patients per type of bariatric procedure) and 20 individuals without type 2 diabetes and obesity who will serve as controls. Bone density and factors that may influence bone density (including improved diabetes control and changes in abdominal fat, muscle mass, physical activity, nutrition, hormones, etc.) will be evaluated before surgery and at 1 and 2 years after surgery.

Relevance to diabetes: This study is important for both the patient with type 2 diabetes undergoing bariatric surgery and healthcare professionals to inform on the benefits and risks of each bariatric procedure. It will also help identify factors that could be tested to prevent or treat bone fragility in people with type 2 diabetes.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population This is a multi-centre, prospective and observational study comprising 3 bariatric groups namely SG, RYGB and BPD (n=35/group) and one control group (n=20). Bariatric groups will include adult men and women with type 2 diabetes and obesity undergoing bariatric surgery and followed at 0, 1 and 2 years after surgery, and the control group will consist of 20 individuals with a normal BMI and normoglycemia matched for age and sex and assessed at a single visit.
Condition
  • Bariatric Surgery
  • Bone Health
  • Obesity, Morbid
  • Diabetes Mellitus, Type 2
Intervention Procedure: Bariatric surgery
Sleeve gastrectomy, Roux-in-Y gastric bypass or biliopancreatic diversion with duodenal switch
Study Groups/Cohorts
  • Sleeve gastrectomy
    35 Men and women with type 2 diabetes and obesity undergoing bariatric surgery : Sleeve gastrectomy
    Intervention: Procedure: Bariatric surgery
  • Roux-in-Y gastric bypass
    35 Men and women with type 2 diabetes and obesity undergoing bariatric surgery : Roux-in-Y gastric bypass
    Intervention: Procedure: Bariatric surgery
  • Biliopancreatic diversion with duodenal switch
    35 Men and women with type 2 diabetes and obesity undergoing bariatric surgery : Biliopancreatic diversion with duodenal switch
    Intervention: Procedure: Bariatric surgery
  • Control
    20 Men and women with a normal BMI and normoglycemia matched for age and sex with bariatric groups
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: March 5, 2018)
125
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 1, 2020
Estimated Primary Completion Date July 1, 2020   (Final data collection date for primary outcome measure)
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); who are awaiting bariatric surgery. Control group: BMI 18.5 to 24.9 kg/m2; with normoglycemia: HbA1c <6.0%, fasting glucose <6.0 mM and 2-h glucose post 75g OGTT <7.8 mM.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sarah Chouinard-Castonguay 4185254444 ext 48729 Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03455868
Other Study ID Numbers MP-10-2018-2957
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Claudia Gagnon, CHU de Quebec-Universite Laval
Study Sponsor CHU de Quebec-Universite Laval
Collaborators McGill University Health Center
Investigators
Principal Investigator: Claudia Gagnon, Dr CHU de Québec - Université Laval
PRS Account CHU de Quebec-Universite Laval
Verification Date April 2018