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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 : December 23, 2019
Sponsor:
Collaborator:
McGill University Health Centre/Research Institute of the McGill University Health Centre
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 evaluate the impact of the 2 most popular bariatric procedures worldwide (SG, RYGB) 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; (2) to compare vBMD and its potential determinants after bariatric surgery with controls with a normal BMI and normoglycemia ; (3) to compare changes in vBMD and its potential determinants after SG (the most popular bariatric procedure) with obese controls without diabetes.

Exploratory aims: (1) to evaluate the prevalence and incidence at one year of falls as well as vertebral and non-vertebral fractures after SG and RYGB; (2) to evaluate bone microarchitecture and metabolism by iliac crest bone biopsy in patients with obesity, with or without type 2 diabetes, before SG.


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

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Study Type : Observational
Estimated Enrollment : 135 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, 2021
Estimated Study Completion Date : December 1, 2021

Resource links provided by the National Library of Medicine


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

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

Sleeve gastrectomy no diabetes
35 Men and women without type 2 diabetes and with obesity undergoing bariatric surgery : Sleeve gastrectomy
Procedure: Bariatric surgery
Sleeve gastrectomy or Roux-in-Y gastric bypass

Control
30 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 and 1 year 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 and 1 year after bariatric surgery ]
    serum bone formation marker

  2. Change in osteocalcin (total and under-carboxylated) [ Time Frame: before and 1 year after bariatric surgery ]
    serum bone formation marker

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

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

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

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

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

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

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

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

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

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

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

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

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

  16. Change in ghrelin [ Time Frame: before and 1 year 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 and 1 year after bariatric surgery ]
    body composition

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

  19. Change in muscle fat content by quantitative computed tomography (QCT) [ Time Frame: before and 1 year after bariatric surgery ]
    body composition

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

  21. Change in upper extremity muscle strength [ Time Frame: before and 1 year after bariatric surgery ]
    by hand grip strength

  22. Change in lower extremity muscle strength [ Time Frame: before and 1 year after bariatric surgery ]
    knee extensor strength

  23. Change in muscle mass (muscle cross-sectional area) and function [ Time Frame: before and 1 year after bariatric surgery ]
    by timed up and go test

  24. Change in muscle mass (muscle cross-sectional area) and function [ Time Frame: before and 1 year after bariatric surgery ]
    by 6-minute walk test

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

  26. Change in sociodemographic factors [ Time Frame: before and 1 year after bariatric surgery ]
    questionnaire

  27. Change in nutrition [ Time Frame: before and 1 year after bariatric surgery ]
    3 web-based 24-h recalls

  28. Change in reported physical activity [ Time Frame: before and 1 year after bariatric surgery ]
    by questionnaire

  29. Change in measured physical activity [ Time Frame: before and 1 year after bariatric surgery ]
    by accelerometer

  30. Change in gut microbiota [ Time Frame: before and 1 year after bariatric surgery ]
    stool sample

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


Other Outcome Measures:
  1. Bone microarchitecture and metabolism [ Time Frame: before surgery ]
    by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry, only for the SG groups

  2. Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5) [ Time Frame: before and 1 year after bariatric surgery ]
    Using the algorithm-based qualitative method (ABQ) and the Genant method and non-vertebral fractures (self-reported)

  3. Prevalence and incidence of falls [ Time Frame: before and 1 year after bariatric surgery ]
    by questionnaire


Biospecimen Retention:   Samples Without DNA
Blood (serum and plasma)


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.


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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 2 bariatric groups with diabetes undergoing SG or RYGB (n=70), one bariatric group without diabetes undergoing SG (n=35) and one control group (n=30). Bariatric groups will include adult men and women with or without type 2 diabetes and obesity undergoing bariatric surgery and followed at 0, 4 months, 8 months and 1 year after surgery, and the control group will consist of 30 individuals with a normal BMI and normoglycemia matched for age, menopausal status 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);) or without diabetes: HbA1c <6.5% AND fasting glucose <7.0 mM; 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
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Contact: Sarah Chouinard-Castonguay 4185254444 ext 48729 Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca

Locations
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Canada, Quebec
The Research Institute of the McGill University Health Centre 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 Centre/Research Institute of the McGill University Health Centre
Investigators
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Principal Investigator: Claudia Gagnon, Dr CHU de Québec - Université Laval
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Responsible Party: Claudia Gagnon, Dr, CHU de Quebec-Universite Laval
ClinicalTrials.gov Identifier: NCT03455868    
Other Study ID Numbers: MP-10-2018-2957
First Posted: March 7, 2018    Key Record Dates
Last Update Posted: December 23, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity, Morbid
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight