ClinicalTrials.gg
RecruitingNCT03455868BODIUpdated Jun 10, 2025

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

An observational study in Bariatric Surgery, Bone Health and Obesity, Morbid, sponsored by CHU de Quebec-Universite Laval. Recruiting at 3 sites in Canada. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-10.

Sponsored by CHU de Quebec-Universite Laval · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Mar 2018; still recruiting 8 years 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 32 studies in Obesity, Morbid with a site in Canada — 7 open to participants now, 10 under way, none of them phase 3. Obesity, Morbid · Canada.

Planned enrollment
8th of 10
100 · median 145
Started
2018
with 2 others
Observational
10 of 32
3 open now
Registered
18th of 32
by date
Lead sponsor
2 of 32
CHU de Quebec-Universite Laval

Among the 32 studies in Obesity, Morbid with a site in Canada, this one is the 8th largest by planned enrollment of the 10 observational ones that give a count, is one of 3 that started in 2018, is one of 10 observational ones, and was the 18th registered.

Obesity, Morbid

941 studies on the registry are indexed under Obesity, Morbid; 163 are open to participants now.

Browse Obesity, Morbid studies →

Open to participants now

7 of the 32 studies in Obesity, Morbid with a site in Canada are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →

Who these studies take

Of the 109 Obesity, Morbid studies recruiting now, 21 (19%) set no upper age limit and 83 (76%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 32 studies in Obesity, Morbid with a site in Canada, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Bariatric Surgery
  • Bone Health
  • Obesity, Morbid
  • Diabetes Mellitus, Type 2
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • bariatric groups: men and women; 18 to 60 years old; with a >=35 kg/m2; with type 2 diabetes: use of oral hypoglycemic agents or insulin OR 2 of the following tests confirming type 2 diabetes: >=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

Exclusion Criteria:

  • bariatric groups: type 1 diabetes; disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, \<60 ml/min) or medication (e.g. , anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism; >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 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.

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Sleeve gastrectomy diabetes

    70 Men and women with or without type 2 diabetes and obesity undergoing sleeve gastrectomy

    Procedure: Bariatric surgery

  • Control without obesity or diabetes

    30 Men and women who are overweight (without obesity) and without diabetes

Interventions

  • ProcedureBariatric surgery

    Sleeve gastrectomy

06

What researchers measure

Primary outcomes

  1. Change in volumetric bone mineral density (vBMD) at lumbar spine, hip, tibia and radius

    assessed by quantitative computed tomography (QCT)

    Time frame: before, 1 year after and 3 years after bariatric surgery

  2. Change in areal bone mineral density at lumbar spine, hip and radius

    assessed by dual-energy X-ray absorptiometry (DXA)

    Time frame: before, 1 year after and 3 years after bariatric surgery

Secondary outcomes

  1. Change in N-terminal propeptide of type 1 procollagen (P1NP)

    serum bone formation marker

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  2. Change in osteocalcin (total, gamma-carboxylated and and under-carboxylated)

    serum bone formation marker

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  3. Change in bone alkaline phosphatase

    serum bone formation marker

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  4. Change in C-telopeptide

    serum bone resorption marker

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  5. Change in fasting glucose

    diabetes control

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  6. Change in HbA1c

    diabetes control

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  7. Change in fasting insulin

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  8. Change in serum 25-hydroxyvitamin D

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  9. Change in parathormone (PTH)

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  10. Change in estradiol and estrone

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  11. Change in insulin like growth factor (IGF)-1

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  12. Change in sclerostin

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  13. Change in adiponectin

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  14. Change in leptin

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  15. Change in peptide YY (PYY)

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  16. Change in ghrelin

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  17. Change in oxidative stress markers

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  18. Change in serum advanced glycation end products (AGEs)

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  19. Change in Free fatty acids (FFA)

    hormones involved in bone metabolism

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  20. Change in fat and lean mass

    body composition assessed by bioimpedance and by DXA

    Time frame: before, 1 year after and 3 years after bariatric surgery

  21. Change in visceral and subcutaneous adipose tissue

    body composition assessed by computed tomography (CT)

    Time frame: before, 1 year after and 3 years after bariatric surgery

  22. Change in muscle mass and fat content at mid-femur

    assessed by computed tomography (CT)

    Time frame: before, 1 year after and 3 years after bariatric surgery

  23. Change in upper extremity muscle strength

    assessed by hand grip strength

    Time frame: before, 1 year after and 3 years after bariatric surgery

  24. Change in lower extremity muscle strength

    assessed by knee extensor strength

    Time frame: before, 1 year after and 3 years after bariatric surgery

  25. Change in muscle function

    assessed by timed up and go test

    Time frame: before, 1 year after and 3 years after bariatric surgery

  26. Change in physical capacity

    assessed by 6-minute walk test

    Time frame: before, 1 year after and 3 years after bariatric surgery

  27. Change in balance

    assessed by Fullerton Advanced Balance (FAB) Scale

    Time frame: before and 1 year after bariatric surgery

  28. Change in sociodemographic factors

    questionnaire

    Time frame: before, 1 year after and 3 years after bariatric surgery

  29. Change in nutrition

    3 web-based 24-h recalls

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  30. Change in self-reported physical activity level

    by questionnaire

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

  31. Change in measured physical activity level

    by accelerometer

    Time frame: before, 1 year after and 3 years after bariatric surgery

  32. Change in gut microbiota

    stool sample

    Time frame: before, 1 year after and 3 years after bariatric surgery

  33. Change in cutaneous Advanced glycation end products (AGEs)

    skin autofluorescence

    Time frame: before, 4 months after, 8 months after, 1 year after and 3 years after bariatric surgery

Other outcomes

  1. Bone microarchitecture and metabolism

    by iliac crest bone biopsy after tetracycline labelling using standard histomorphometry

    Time frame: during surgery

  2. Prevalence and incidence of vertebral fractures (by a CT scout of T4-L5)

    Using the algorithm-based qualitative method (ABQ) and the Genant method

    Time frame: before, 1 year after and 3 years after bariatric surgery

  3. Prevalence and incidence of falls

    by questionnaire

    Time frame: before, 1 year after and 3 years after bariatric surgery

  4. Prevalence and incidence of non-vertebral fractures

    by questionnaire (self-reported)

    Time frame: before, 1 year after and 3 years after bariatric surgery

07

Study locations

1 of 3 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Dec 2025, 92 months after the start.

Of 137 non-industry observational studies under Obesity, Morbid, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 132. This study's planned 92 months is above that.

Counting every sponsor, half of 138 studies reached it within 46 months; a quarter within 16 and three quarters within 132.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 19, 2018
First posted
Mar 7, 2018
StartActual
Mar 15, 2018
Primary completionEst.
Dec 1, 2025
CompletionEst.
Dec 1, 2025
Last update
Jun 10, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 10, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03455868
Responsible party
Claudia Gagnon (Dr, CHU de Quebec-Universite Laval) — Principal investigator
First posted
Mar 7, 2018
Start date
Mar 15, 2018
Primary completion
Dec 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jun 10, 2025

Study contacts

Sarah Chouinard-Castonguay
Contact
Sarah.Chouinard-Castonguay@crchudequebec.ulaval.ca
4185254444 ext. 48729
Claudia Gagnon, Dr
principal investigator · CHU de Québec - Université Laval

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion