Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
- Conditions
- ObesityFractures, BoneOsteoporotic FracturesOsteoporosisMusculoskeletal DiseasesDiabetes MellitusDiabetes Mellitus, Type 2FallBody WeightBone Diseases, Metabolic
- Registration Number
- NCT04093856
- Lead Sponsor
- Suzanne Morin
- Brief 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.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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)
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Muscle composition measured as muscle fat content at the proximal femur Baseline Measured by quantitative computed tomography (QCT)
Muscle size measured as cross-sectional muscle area at the proximal femur Baseline Measured by quantitative computed tomography (QCT)
Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia Baseline Measured by quantitative computed tomography (QCT)
- Secondary Outcome Measures
Name Time Method Lower extremity muscle strength measured by peak torque generated by knee extension Baseline Measured using Biodex isokinetic dynamometer
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. Baseline Measured using Timed Up and Go test.
Functional exercise capacity measured by total distance ambulated during a 6 minute time period Baseline Measured using Six Minute Walk Test
Leptin concentration Baseline Hormone involved in bone metabolism
Physical health Baseline SF-12
Osteocalcin (total and decarboxylated) concentration Baseline Serum bone formation marker
Bone specific alkaline phosphatase concentration Baseline Serum bone formation marker
N-terminal propeptide of type 1 procollagen concentration Baseline Serum bone formation marker
C-telopeptide concentration Baseline Serum bone resorption marker
Insulin concentration Baseline Hormone involved in bone metabolism
Parathormone concentration Baseline Hormone involved in bone metabolism
Estradiol concentration Baseline Hormone involved in bone metabolism
Body composition measured as visceral and subcutaneous adipose tissue Baseline Measured by computed tomography (CT)
Upper extremity muscle strength measured by grip force in kg Baseline Measured using Jamar Hydraulic Hand Dynamometer
Sclerostin concentration Baseline Hormone involved in bone metabolism
Fasting Hemoglobin A1c concentration Baseline Diabetes control
Body composition measured by fat and lean mass Baseline Measured using dual-energy X-ray absorptiometry (DXA)
Bone marrow adiposity Baseline Measured by computed tomography (CT)
Cutaneous Advanced glycation end products (AGEs) measurement Baseline Measured by measured by AGE Reader
Fasting glucose concentration Baseline Diabetes control
Serum 25-hydroxyvitamin D concentration Baseline Hormone involved in bone metabolism
Insulin like growth factor-1 concentration Baseline Hormone involved in bone metabolism
Adiponectin concentration Baseline Hormone involved in bone metabolism
Self-reported physical activity measured in metabolic equivalents (MET) Baseline Measured using the International Physical Activity Questionnaire
Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities Baseline Fullerton Advanced Balance (FAB) Scale
Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days Baseline Actigraph GT3X+ Accelerometer
Community Participation Restriction Baseline Life-space mobility assessment
Health-related quality of life Baseline How are you today? Visual analogue scale
Trial Locations
- Locations (2)
Research Institute of the McGill University Health Centre
🇨🇦Montréal, Quebec, Canada
Centre de recherche de l'IUCPQ
🇨🇦Québec, Canada