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OpenTrials
Completed

NCT Number: NCT04093856

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

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.

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Key information

Conditions

Diabetes Mellitus Body Weight Bone Diseases Bone Diseases, Metabolic Diabetes Mellitus, Type 2 Endocrine System Diseases Fall Fractures, Bone Glucose Metabolism Disorders Metabolic Diseases Musculoskeletal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Osteoporosis Osteoporotic Fractures Overnutrition Overweight Pathological Conditions, Signs and Symptoms Quality of Life Signs and Symptoms Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Institute of the McGill University Health Centre, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

A) 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)

B) Non-diabetic group:

  • BMI >=35 kg/m2
  • Normoglycemia (HgbA1c <5.7% and Fasting glucose <5.6 nM)

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline

    Measured by quantitative computed tomography (QCT)

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

    Time frame: Baseline

    Measured by quantitative computed tomography (QCT)

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

    Time frame: Baseline

    Measured by quantitative computed tomography (QCT)

Secondary outcomes

  1. N-terminal propeptide of type 1 procollagen concentration

    Time frame: Baseline

    Serum bone formation marker

  2. Osteocalcin (total and decarboxylated) concentration

    Time frame: Baseline

    Serum bone formation marker

  3. Bone specific alkaline phosphatase concentration

    Time frame: Baseline

    Serum bone formation marker

  4. C-telopeptide concentration

    Time frame: Baseline

    Serum bone resorption marker

  5. Fasting glucose concentration

    Time frame: Baseline

    Diabetes control

  6. Fasting Hemoglobin A1c concentration

    Time frame: Baseline

    Diabetes control

  7. Insulin concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  8. Serum 25-hydroxyvitamin D concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  9. Parathormone concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  10. Estradiol concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  11. Insulin like growth factor-1 concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  12. Sclerostin concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  13. Adiponectin concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  14. Leptin concentration

    Time frame: Baseline

    Hormone involved in bone metabolism

  15. Body composition measured as visceral and subcutaneous adipose tissue

    Time frame: Baseline

    Measured by computed tomography (CT)

  16. Body composition measured by fat and lean mass

    Time frame: Baseline

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

  17. Bone marrow adiposity

    Time frame: Baseline

    Measured by computed tomography (CT)

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

    Time frame: Baseline

    Measured using Jamar Hydraulic Hand Dynamometer

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

    Time frame: Baseline

    Measured using Biodex isokinetic dynamometer

  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.

    Time frame: Baseline

    Measured using Timed Up and Go test.

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

    Time frame: Baseline

    Measured using Six Minute Walk Test

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

    Time frame: Baseline

    Measured using the International Physical Activity Questionnaire

  23. Cutaneous Advanced glycation end products (AGEs) measurement

    Time frame: Baseline

    Measured by measured by AGE Reader

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

    Time frame: Baseline

    Actigraph GT3X+ Accelerometer

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

    Time frame: Baseline

    Fullerton Advanced Balance (FAB) Scale

  26. Physical health

    Time frame: Baseline

    SF-12

  27. Community Participation Restriction

    Time frame: Baseline

    Life-space mobility assessment

  28. Health-related quality of life

    Time frame: Baseline

    How are you today? Visual analogue scale

Sponsors and collaborators

Lead sponsor

Suzanne Morin

Other

Collaborators

  • CHU de Quebec-Universite Laval

Registry information

Acronym: BODI2

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 18, 2019
Registry last updated
Sep 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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