An observational study in Diabetes Mellitus, Diabetes Mellitus, Type 2 and Obesity, sponsored by Suzanne Morin. Completed at 2 sites in Canada. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-09-01.
Sponsored by Suzanne Morin · Observational
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 40 is below the median of 174 across 446 observational studies indexed under Osteoporosis.
Browse Osteoporosis studies →This is the only study on the registry with Suzanne Morin as lead sponsor.
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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.
A) Diabetic group
B) Non-diabetic group:
Exclusion Criteria:
20 men and women with type 2 diabetes and obesity
20 normoglycemic men and women with obesity matched for age and sex with diabetic group
Muscle size measured as cross-sectional muscle area at the proximal femur
Measured by quantitative computed tomography (QCT)
Time frame: Baseline
Muscle composition measured as muscle fat content at the proximal femur
Measured by quantitative computed tomography (QCT)
Time frame: Baseline
Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia
Measured by quantitative computed tomography (QCT)
Time frame: Baseline
N-terminal propeptide of type 1 procollagen concentration
Serum bone formation marker
Time frame: Baseline
Osteocalcin (total and decarboxylated) concentration
Serum bone formation marker
Time frame: Baseline
Bone specific alkaline phosphatase concentration
Serum bone formation marker
Time frame: Baseline
C-telopeptide concentration
Serum bone resorption marker
Time frame: Baseline
Fasting glucose concentration
Diabetes control
Time frame: Baseline
Fasting Hemoglobin A1c concentration
Diabetes control
Time frame: Baseline
Insulin concentration
Hormone involved in bone metabolism
Time frame: Baseline
Serum 25-hydroxyvitamin D concentration
Hormone involved in bone metabolism
Time frame: Baseline
Parathormone concentration
Hormone involved in bone metabolism
Time frame: Baseline
Estradiol concentration
Hormone involved in bone metabolism
Time frame: Baseline
Insulin like growth factor-1 concentration
Hormone involved in bone metabolism
Time frame: Baseline
Sclerostin concentration
Hormone involved in bone metabolism
Time frame: Baseline
Adiponectin concentration
Hormone involved in bone metabolism
Time frame: Baseline
Leptin concentration
Hormone involved in bone metabolism
Time frame: Baseline
Body composition measured as visceral and subcutaneous adipose tissue
Measured by computed tomography (CT)
Time frame: Baseline
Body composition measured by fat and lean mass
Measured using dual-energy X-ray absorptiometry (DXA)
Time frame: Baseline
Bone marrow adiposity
Measured by computed tomography (CT)
Time frame: Baseline
Upper extremity muscle strength measured by grip force in kg
Measured using Jamar Hydraulic Hand Dynamometer
Time frame: Baseline
Lower extremity muscle strength measured by peak torque generated by knee extension
Measured using Biodex isokinetic dynamometer
Time frame: Baseline
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.
Time frame: Baseline
Functional exercise capacity measured by total distance ambulated during a 6 minute time period
Measured using Six Minute Walk Test
Time frame: Baseline
Self-reported physical activity measured in metabolic equivalents (MET)
Measured using the International Physical Activity Questionnaire
Time frame: Baseline
Cutaneous Advanced glycation end products (AGEs) measurement
Measured by measured by AGE Reader
Time frame: Baseline
Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days
Actigraph GT3X+ Accelerometer
Time frame: Baseline
Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities
Fullerton Advanced Balance (FAB) Scale
Time frame: Baseline
Physical health
SF-12
Time frame: Baseline
Community Participation Restriction
Life-space mobility assessment
Time frame: Baseline
Health-related quality of life
How are you today? Visual analogue scale
Time frame: Baseline
Plan to share: No
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This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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