BODI2: Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes

Sponsor

Suzanne Morin (Other)

Overall Status

Completed

CT.gov ID

NCT04093856

Collaborator

CHU de Quebec-Universite Laval (Other)

Enrollment

Locations

Actual Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Body Weight Bone Diseases, Metabolic Fractures, Bone Osteoporotic Fractures Osteoporosis Quality of Life Fall Musculoskeletal Diseases

Study Design

Study Type:

Observational

Actual Enrollment :

40 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 14, 2020

Actual Primary Completion Date :

Jun 14, 2021

Actual Study Completion Date :

Jun 14, 2021

Arms and Interventions

Arm	Intervention/Treatment
Diabetic 20 men and women with type 2 diabetes and obesity
Non-diabetic 20 normoglycemic men and women with obesity matched for age and sex with diabetic group

Outcome Measures

Primary Outcome Measures

Muscle size measured as cross-sectional muscle area at the proximal femur [Baseline]
Measured by quantitative computed tomography (QCT)
Muscle composition measured as muscle fat content 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

N-terminal propeptide of type 1 procollagen concentration [Baseline]
Serum bone formation marker
Osteocalcin (total and decarboxylated) concentration [Baseline]
Serum bone formation marker
Bone specific alkaline phosphatase concentration [Baseline]
Serum bone formation marker
C-telopeptide concentration [Baseline]
Serum bone resorption marker
Fasting glucose concentration [Baseline]
Diabetes control
Fasting Hemoglobin A1c concentration [Baseline]
Diabetes control
Insulin concentration [Baseline]
Hormone involved in bone metabolism
Serum 25-hydroxyvitamin D concentration [Baseline]
Hormone involved in bone metabolism
Parathormone concentration [Baseline]
Hormone involved in bone metabolism
Estradiol concentration [Baseline]
Hormone involved in bone metabolism
Insulin like growth factor-1 concentration [Baseline]
Hormone involved in bone metabolism
Sclerostin concentration [Baseline]
Hormone involved in bone metabolism
Adiponectin concentration [Baseline]
Hormone involved in bone metabolism
Leptin concentration [Baseline]
Hormone involved in bone metabolism
Body composition measured as visceral and subcutaneous adipose tissue [Baseline]
Measured by computed tomography (CT)
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)
Upper extremity muscle strength measured by grip force in kg [Baseline]
Measured using Jamar Hydraulic Hand Dynamometer
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
Self-reported physical activity measured in metabolic equivalents (MET) [Baseline]
Measured using the International Physical Activity Questionnaire
Cutaneous Advanced glycation end products (AGEs) measurement [Baseline]
Measured by measured by AGE Reader
Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days [Baseline]
Actigraph GT3X+ Accelerometer
Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities [Baseline]
Fullerton Advanced Balance (FAB) Scale
Physical health [Baseline]
SF-12
Community Participation Restriction [Baseline]
Life-space mobility assessment
Health-related quality of life [Baseline]
How are you today? Visual analogue scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.