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Recruiting NCT03455868

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

— Observational Bariatric Surgery Bone Health Obesity, Morbid Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Bariatric surgery.
Who it may be relevant to
Registry conditions: Bariatric Surgery, Bone Health, Obesity, Morbid, Diabetes Mellitus, Type 2. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Procedure Bariatric surgery
    Sleeve gastrectomy

Primary outcome measures

  • Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius [Time frame: before, 1 year after and 3 years after bariatric surgery]
  • Change in areal bone mineral density at lumbar spine, hip and radius [Time frame: before, 1 year after and 3 years after bariatric surgery]
Secondary outcome measures (12)
  • Change in N-terminal propeptide of type 1 procollagen (P1NP) [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated) [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in bone alkaline phosphatase [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in C-telopeptide [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in fasting glucose [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in HbA1c [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in fasting insulin [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in serum 25-hydroxyvitamin D [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in parathormone (PTH) [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in estradiol and estrone [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in insulin like growth factor (IGF)-1 [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]
  • Change in sclerostin [Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Canada · 3 centers
  • The Research Institute of the McGill University Health Centre — Montreal
  • Centre de recherche du CHU de Québec - Université Laval — Québec
  • Centre de recherche de l'IUCPQ — Québec

Identifiers

NCT: NCT03455868 · MP-10-2018-2957

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗