Bariatric SurgeryBODINCT03455868
Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
An observational study of Bariatric Surgery and Bone Health, run by CHU de Quebec-Universite Laval at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Bariatric Surgery, Bone Health, Obesity, Morbid
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 3 sitesCanada
- Study dates
- 15 Mar 2018to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Chouinard-Castonguay contact
Canada3 sites, 1 recruiting
- Terminated
The Research Institute of the McGill University Health Centre
Montreal, Quebec, H3H 2R9
- Active, not recruiting
Centre de recherche du CHU de Québec - Université Laval
Québec, Quebec, G1V 4G2
- Recruiting
Centre de recherche de l'IUCPQ
Québec, Quebec, G1V 4G5
Sarah Chouinard-Castonguay, 4185254444 ext. 48729, Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca
Gagnon Claudia, Dr
About this study
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.
Read the 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.
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity, Morbid, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Sleeve gastrectomy
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy diabetes | 70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy Receives: Procedure: Bariatric surgery | |
| Control without obesity or diabetes | 30 Men and women who are overweight (without obesity) and without diabetes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius
assessed by quantitative computed tomography (QCT)
Measured: before, 1 year after and 3 years after bariatric surgery
Change in areal bone mineral density at lumbar spine, hip and radius
assessed by dual-energy X-ray absorptiometry (DXA)
Measured: before, 1 year after and 3 years after bariatric surgery
Secondary outcomes (33)
Change in N-terminal propeptide of type 1 procollagen (P1NP)
serum bone formation marker
Measured: 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)
serum bone formation marker
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in bone alkaline phosphatase
serum bone formation marker
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in C-telopeptide
serum bone resorption marker
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in fasting glucose
diabetes control
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in HbA1c
diabetes control
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in fasting insulin
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in serum 25-hydroxyvitamin D
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in parathormone (PTH)
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in estradiol and estrone
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in insulin like growth factor (IGF)-1
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in sclerostin
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in adiponectin
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in leptin
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in peptide YY (PYY)
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in ghrelin
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in oxidative stress markers
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in serum advanced glycation end products (AGEs)
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in Free fatty acids (FFA)
hormones involved in bone metabolism
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in fat and lean mass
body composition assessed by bioimpedance and by DXA
Measured: before, 1 year after and 3 years after bariatric surgery
Change in visceral and subcutaneous adipose tissue
body composition assessed by computed tomography (CT)
Measured: before, 1 year after and 3 years after bariatric surgery
Change in muscle mass and fat content at mid-femur
assessed by computed tomography (CT)
Measured: before, 1 year after and 3 years after bariatric surgery
Change in upper extremity muscle strength
assessed by hand grip strength
Measured: before, 1 year after and 3 years after bariatric surgery
Change in lower extremity muscle strength
assessed by knee extensor strength
Measured: before, 1 year after and 3 years after bariatric surgery
Change in muscle function
assessed by timed up and go test
Measured: before, 1 year after and 3 years after bariatric surgery
Change in physical capacity
assessed by 6-minute walk test
Measured: before, 1 year after and 3 years after bariatric surgery
Change in balance
assessed by Fullerton Advanced Balance (FAB) Scale
Measured: before and 1 year after bariatric surgery
Change in sociodemographic factors
questionnaire
Measured: before, 1 year after and 3 years after bariatric surgery
Change in nutrition
3 web-based 24-h recalls
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in self-reported physical activity level
by questionnaire
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Change in measured physical activity level
by accelerometer
Measured: before, 1 year after and 3 years after bariatric surgery
Change in gut microbiota
stool sample
Measured: before, 1 year after and 3 years after bariatric surgery
Change in cutaneous Advanced glycation end products (AGEs)
skin autofluorescence
Measured: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start15 Mar 2018
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Claudia Gagnon, CHU de Quebec-Universite Laval
- Investigators
- Claudia Gagnon, Dr, Principal investigator, CHU de Québec - Université Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455868
- Sponsor's protocol ID
- MP-10-2018-2957
- Acronym
- BODI
- Status last verified
- Jun 2025
- First submitted
- 19 Feb 2018
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03455868
- Acronym / sponsor ID
- BODI / MP-10-2018-2957
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Collaborators
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 15 Mar 2018 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve gastrectomy diabetes | – | Procedure: Bariatric surgery70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy |
| Control without obesity or diabetes | – | –30 Men and women who are overweight (without obesity) and without diabetes |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric surgerySleeve gastrectomy | Procedure or surgery | Sleeve gastrectomy diabetes |
Primary outcome
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)
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)
33 secondary outcomes
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
Change in adiponectin
Time frame: 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
Change in peptide YY (PYY)
Time frame: 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
Change in oxidative stress markers
Time frame: 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
Change in Free fatty acids (FFA)
Time frame: 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
Change in visceral and subcutaneous adipose tissue
Time frame: 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
Change in upper extremity muscle strength
Time frame: 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
Change in muscle function
Time frame: 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
Change in balance
Time frame: before and 1 year after bariatric surgery
Change in sociodemographic factors
Time frame: 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
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
Change in measured physical activity level
Time frame: 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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Chouinard-Castonguay contact
Claudia Gagnon, Dr principal investigator
CHU de Québec - Université Laval
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bariatric Surgery and Bone Health, run by CHU de Quebec-Universite Laval at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Chouinard-Castonguay (4185254444 ext. 48729, Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.