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

June 5, 2025 updated by: Claudia Gagnon, CHU de Quebec-Universite Laval
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
      • Quebec, Canada, G1V 4G2
        • Active, not recruiting
        • Centre de recherche du CHU de Québec - Université Laval
    • Quebec
      • Montréal, Quebec, Canada, H3H 2R9
        • Terminated
        • The Research Institute of the McGill University Health Centre
      • Québec, Quebec, Canada, G1V 4G5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sleeve gastrectomy diabetes
70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy
Procedure: Bariatric surgery
Sleeve gastrectomy
Control without obesity or diabetes
30 Men and women who are overweight (without obesity) and without diabetes

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
assessed by quantitative computed tomography (QCT)
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
assessed by dual-energy X-ray absorptiometry (DXA)
before, 1 year after and 3 years after bariatric surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
serum bone formation marker
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
serum bone formation marker
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
serum bone formation marker
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
serum bone resorption marker
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
diabetes control
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
diabetes control
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
hormones involved in bone metabolism
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
hormones involved in bone metabolism
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
hormones involved in bone metabolism
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
hormones involved in bone metabolism
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
hormones involved in bone metabolism
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
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in adiponectin
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in leptin
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in peptide YY (PYY)
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in ghrelin
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in oxidative stress markers
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in serum advanced glycation end products (AGEs)
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in Free fatty acids (FFA)
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
hormones involved in bone metabolism
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in fat and lean mass
Time Frame: before, 1 year after and 3 years after bariatric surgery
body composition assessed by bioimpedance and by DXA
before, 1 year after and 3 years after bariatric surgery
Change in visceral and subcutaneous adipose tissue
Time Frame: before, 1 year after and 3 years after bariatric surgery
body composition assessed by computed tomography (CT)
before, 1 year after and 3 years after bariatric surgery
Change in muscle mass and fat content at mid-femur
Time Frame: before, 1 year after and 3 years after bariatric surgery
assessed by computed tomography (CT)
before, 1 year after and 3 years after bariatric surgery
Change in upper extremity muscle strength
Time Frame: before, 1 year after and 3 years after bariatric surgery
assessed by hand grip strength
before, 1 year after and 3 years after bariatric surgery
Change in lower extremity muscle strength
Time Frame: before, 1 year after and 3 years after bariatric surgery
assessed by knee extensor strength
before, 1 year after and 3 years after bariatric surgery
Change in muscle function
Time Frame: before, 1 year after and 3 years after bariatric surgery
assessed by timed up and go test
before, 1 year after and 3 years after bariatric surgery
Change in physical capacity
Time Frame: before, 1 year after and 3 years after bariatric surgery
assessed by 6-minute walk test
before, 1 year after and 3 years after bariatric surgery
Change in balance
Time Frame: before and 1 year after bariatric surgery
assessed by Fullerton Advanced Balance (FAB) Scale
before and 1 year after bariatric surgery
Change in sociodemographic factors
Time Frame: before, 1 year after and 3 years after bariatric surgery
questionnaire
before, 1 year after and 3 years after bariatric surgery
Change in nutrition
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
3 web-based 24-h recalls
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in self-reported physical activity level
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
by questionnaire
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in measured physical activity level
Time Frame: before, 1 year after and 3 years after bariatric surgery
by accelerometer
before, 1 year after and 3 years after bariatric surgery
Change in gut microbiota
Time Frame: before, 1 year after and 3 years after bariatric surgery
stool sample
before, 1 year after and 3 years after bariatric surgery
Change in cutaneous Advanced glycation end products (AGEs)
Time Frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
skin autofluorescence
before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone microarchitecture and metabolism
Time Frame: during surgery
by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry
during surgery
Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5)
Time Frame: before, 1 year after and 3 years after bariatric surgery
Using the algorithm-based qualitative method (ABQ) and the Genant method
before, 1 year after and 3 years after bariatric surgery
Prevalence and incidence of falls
Time Frame: before, 1 year after and 3 years after bariatric surgery
by questionnaire
before, 1 year after and 3 years after bariatric surgery
Prevalence and incidence of non-vertebral fractures
Time Frame: before, 1 year after and 3 years after bariatric surgery
by questionnaire (self-reported)
before, 1 year after and 3 years after bariatric surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Quebec-Universite Laval

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia Gagnon, Dr, CHU de Québec - Université Laval

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 15, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MP-10-2018-2957

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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