ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.


Condition or disease Intervention/treatment
Bariatric Surgery Bone Health Obesity, Morbid Diabetes Mellitus, Type 2 Procedure: Bariatric surgery

Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Sleeve gastrectomy
35 Men and women with type 2 diabetes and obesity undergoing bariatric surgery : Sleeve gastrectomy
Procedure: Bariatric surgery
Sleeve gastrectomy, Roux-in-Y gastric bypass or biliopancreatic diversion with duodenal switch

Roux-in-Y gastric bypass
35 Men and women with type 2 diabetes and obesity undergoing bariatric surgery : Roux-in-Y gastric bypass
Procedure: Bariatric surgery
Sleeve gastrectomy, Roux-in-Y gastric bypass or biliopancreatic diversion with duodenal switch

Biliopancreatic diversion with duodenal switch
35 Men and women with type 2 diabetes and obesity undergoing bariatric surgery : Biliopancreatic diversion with duodenal switch
Procedure: Bariatric surgery
Sleeve gastrectomy, Roux-in-Y gastric bypass or biliopancreatic diversion with duodenal switch

Control
20 Men and women with a normal BMI and normoglycemia matched for age and sex with bariatric groups



Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Change in N-terminal propeptide of type 1 procollagen (P1NP) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker

  2. Change in osteocalcin (total and decarboxylated) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker

  3. Change in bone alkaline phosphatase [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone formation marker

  4. Change in C-telopeptide [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    serum bone resorption marker

  5. Change in fasting glucose [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    diabetes control

  6. Change in HbA1c [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    diabetes control

  7. Change in fasting insulin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  8. Change in serum 25-hydroxyvitamin D [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  9. Change in parathormone (PTH) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  10. Change in estradiol and estrange [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  11. Change in insulin like growth factor (IGF)-1 [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  12. Change in sclerostin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  13. Change in adiponectin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  14. Change in leptin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  15. Change in peptide YY (PYY) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  16. Change in ghrelin [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    hormones involved in bone metabolism

  17. 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

  18. Change in visceral and subcutaneous adipose tissue by quantitative computed tomography (QCT) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition

  19. Change in bone marrow adiposity by dual-energy quantitative computed tomography (QCT) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    body composition

  20. Change in upper extremity muscle strength [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by hand grip strength

  21. Change in lower extremity muscle strength [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    knee extensor strength

  22. Change in muscle function [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by timed up and go test

  23. Change in muscle function [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by Fullerton Advanced Balance (FAB) Scale

  24. Change in sociodemographic factors [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    questionnaire

  25. Change in nutrition [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    3 web-based 24-h recalls

  26. Change in reported physical activity [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by questionnaire

  27. Change in measured physical activity [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    by accelerometer

  28. Change in gut microbiota [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    stool sample

  29. Change in menopausal status (Follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
  30. Change in cutaneous Advanced glycation end products (AGEs) [ Time Frame: before, 1 and 2 years after bariatric surgery ]
    skin autofluorescence



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03455868


Contacts
Contact: Sarah Chouinard-Castonguay 4185254444 ext 48729 Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca

Locations
Canada, Quebec
The Research Institute of the McGill University Health Centre Not yet recruiting
Montréal, Quebec, Canada, H3H 2R9
Contact: Vanessa Tardio, Dr       vanessa.tardio@mail.mcgill.ca   
Principal Investigator: Vanessa Tardio, Dr         
Canada
Centre de recherche du CHU de Québec - Université Laval Active, not recruiting
Quebec, Canada, G1V 4G2
Centre de recherche de l'IUCPQ Recruiting
Québec, Canada, G1V 4G5
Contact: Sarah Chouinard-Castonguay    4185254444 ext 48729    Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca   
Principal Investigator: Gagnon Claudia, Dr         
Sponsors and Collaborators
CHU de Quebec-Universite Laval
McGill University Health Center
Investigators
Principal Investigator: Claudia Gagnon, Dr CHU de Québec - Université Laval

Responsible Party: Claudia Gagnon, Dr, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03455868     History of Changes
Other Study ID Numbers: MP-10-2018-2957
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms