AzTrials
AzTrials

Diabetes MellitusBODI2NCT04093856

Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes

An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Suzanne Morin at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Background: Osteoporotic fractures are a major public health issue. They cause substantial disability, loss of autonomy, morbidity and excess mortality. Diabetes is also associated with increased risk for falls and fractures through a direct impact of elevated blood glucose on the skeleton and on muscles. Read more about this study

Who is it for?
Ages 18 to 60 years
How many people
40 participants
Where
2 sitesCanada
Study dates
14 Jan 2020to 14 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

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
  • No healthy volunteers
  • Adult

Study population: This is a multi-center, cross-sectional, observational study comprising of two groups of participants with obesity either with or without diabetes (n=20/group). The diabetic groups will include 20 adult men and women with obesity and type 2 diabetes, and the non-diabetic group will consist of 20 age- and sex- matched individuals with obesity and normoglycemia.

Who may be able to join

  • Diabetic group
  • BMI >=35 kg/m2
  • Clinical diagnosis of 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)
  • Non-diabetic group:
  • BMI >=35 kg/m2
  • Normoglycemia (HgbA1c <5.7% and Fasting glucose <5.6 nM)

Who cannot join

  • BMI >60 kg/m2
  • Clinical diagnosis of type 1 diabetes
  • Disease (e.g. uncontrolled thyroid disease, malabsorptive or overt inflammatory disorder, metabolic bone disease, creatinine clearance <60 ml/min)
  • Medication (e.g. gluccocorticoids, anti-epileptic drugs, osteoporosis therapy and thiazolidinediones) affecting bone metabolism
  • Pregnancy
  • History of oesophageal, gastric, digestive or bariatric surgery
  • Prosthesis that could interfere with interpretation of imaging data
  • Chronic severe condition or illness precluding from participation in the project.

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • Research Institute of the McGill University Health Centre

    Montreal, Quebec, H3H 2R9

  • Centre de recherche de l'IUCPQ

    Québec, G1V 4G5

Other trials in Canada

About this study

Background: Osteoporotic fractures are a major public health issue. They cause substantial disability, loss of autonomy, morbidity and excess mortality. Diabetes is also associated with increased risk for falls and fractures through a direct impact of elevated blood glucose on the skeleton and on muscles.

Research project overview: The investigators propose a cross-sectional study that will involve 2 research centers in the province of Quebec. The investigators will recruit 20 obese participants, without diabetes, who have not undergone bariatric surgery, for one-time measurements to be compared with baseline measurements (pre-surgery) from participants in the bariatric obese diabetic groups with type II diabetes mellitus from the ongoing study BODI study (NCT03455868). Bone Mineral Density as well as muscle quality, strength and function will be evaluated at a single study visit.

Relevance: This data will permit the evaluation of the bone-muscle unit in patients with obesity with and without diabetes, and assess whether the presence and duration of diabetes impacts further on clinical and functional musculoskeletal outcomes (falls, fractures and mobility and strength) in this population. AGEs, if associated with muscle and bone deterioration, might become an easily accessible biomarker of musculoskeletal health in the clinical setting.

Keywords
Advanced glycation end products, Advanced imaging, Mobility, Strength
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 2, Obesity, Body Weight, Bone Diseases, Metabolic, Fractures, Bone, Osteoporotic Fractures, Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04093856
Study groupRoleWhat they receive
Diabetic20 men and women with type 2 diabetes and obesity
Non-diabetic20 normoglycemic men and women with obesity matched for age and sex with diabetic group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Muscle size measured as cross-sectional muscle area at the proximal femur

    Measured by quantitative computed tomography (QCT)

    Measured: Baseline

  2. Muscle composition measured as muscle fat content at the proximal femur

    Measured by quantitative computed tomography (QCT)

    Measured: Baseline

  3. Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia

    Measured by quantitative computed tomography (QCT)

    Measured: Baseline

Secondary outcomes (28)

  1. N-terminal propeptide of type 1 procollagen concentration

    Serum bone formation marker

    Measured: Baseline

  2. Osteocalcin (total and decarboxylated) concentration

    Serum bone formation marker

    Measured: Baseline

  3. Bone specific alkaline phosphatase concentration

    Serum bone formation marker

    Measured: Baseline

  4. C-telopeptide concentration

    Serum bone resorption marker

    Measured: Baseline

  5. Fasting glucose concentration

    Diabetes control

    Measured: Baseline

  6. Fasting Hemoglobin A1c concentration

    Diabetes control

    Measured: Baseline

  7. Insulin concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  8. Serum 25-hydroxyvitamin D concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  9. Parathormone concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  10. Estradiol concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  11. Insulin like growth factor-1 concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  12. Sclerostin concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  13. Adiponectin concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  14. Leptin concentration

    Hormone involved in bone metabolism

    Measured: Baseline

  15. Body composition measured as visceral and subcutaneous adipose tissue

    Measured by computed tomography (CT)

    Measured: Baseline

  16. Body composition measured by fat and lean mass

    Measured using dual-energy X-ray absorptiometry (DXA)

    Measured: Baseline

  17. Bone marrow adiposity

    Measured by computed tomography (CT)

    Measured: Baseline

  18. Upper extremity muscle strength measured by grip force in kg

    Measured using Jamar Hydraulic Hand Dynamometer

    Measured: Baseline

  19. Lower extremity muscle strength measured by peak torque generated by knee extension

    Measured using Biodex isokinetic dynamometer

    Measured: Baseline

  20. Functional mobility measured by time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.

    Measured using Timed Up and Go test.

    Measured: Baseline

  21. Functional exercise capacity measured by total distance ambulated during a 6 minute time period

    Measured using Six Minute Walk Test

    Measured: Baseline

  22. Self-reported physical activity measured in metabolic equivalents (MET)

    Measured using the International Physical Activity Questionnaire

    Measured: Baseline

  23. Cutaneous Advanced glycation end products (AGEs) measurement

    Measured by measured by AGE Reader

    Measured: Baseline

  24. Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days

    Actigraph GT3X+ Accelerometer

    Measured: Baseline

  25. Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities

    Fullerton Advanced Balance (FAB) Scale

    Measured: Baseline

  26. Physical health

    SF-12

    Measured: Baseline

  27. Community Participation Restriction

    Life-space mobility assessment

    Measured: Baseline

  28. Health-related quality of life

    How are you today? Visual analogue scale

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2019
  2. Study start14 Jan 2020
  3. Primary completion14 Jun 2021
  4. Study completion14 Jun 2021

Resources

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
Case-control
Time perspective
Cross-sectional
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04093856
Sponsor's protocol ID
MP-37-2020-5872
Acronym
BODI2
Status last verified
Aug 2021
First submitted
10 Sep 2019
Last updated
1 Sep 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus and Diabetes Mellitus, Type 2, run by Suzanne Morin at 2 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 7 inclusion and 8 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: finished, as of the sponsor's last update on 1 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle size measured as cross-sectional muscle area at the proximal femur (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04093856.

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 1 Sep 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in