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

Obesity Clinical Trial

— BODI2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04093856
• Other study ID #: MP-37-2020-5872
• Status: Completed
• Start date: January 14, 2020
• Est. completion date: June 14, 2021

Study information

• Verified date: August 2021
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 14, 2021
• Est. primary completion date: June 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Body Weight
• Bone Diseases
• Bone Diseases, Metabolic
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Fall
• Fractures, Bone
• Metabolic Diseases
• Musculoskeletal Diseases
• Obesity
• Osteoporosis
• Osteoporotic Fractures
• Quality of Life

Locations

Country	Name	City	State
Canada	Research Institute of the McGill University Health Centre	Montréal	Quebec
Canada	Centre de recherche de l'IUCPQ	Québec

Sponsors (2)

Lead Sponsor	Collaborator
Suzanne Morin	CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle size measured as cross-sectional muscle area at the proximal femur	Measured by quantitative computed tomography (QCT)	Baseline
Primary	Muscle composition measured as muscle fat content at the proximal femur	Measured by quantitative computed tomography (QCT)	Baseline
Primary	Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia	Measured by quantitative computed tomography (QCT)	Baseline
Secondary	N-terminal propeptide of type 1 procollagen concentration	Serum bone formation marker	Baseline
Secondary	Osteocalcin (total and decarboxylated) concentration	Serum bone formation marker	Baseline
Secondary	Bone specific alkaline phosphatase concentration	Serum bone formation marker	Baseline
Secondary	C-telopeptide concentration	Serum bone resorption marker	Baseline
Secondary	Fasting glucose concentration	Diabetes control	Baseline
Secondary	Fasting Hemoglobin A1c concentration	Diabetes control	Baseline
Secondary	Insulin concentration	Hormone involved in bone metabolism	Baseline
Secondary	Serum 25-hydroxyvitamin D concentration	Hormone involved in bone metabolism	Baseline
Secondary	Parathormone concentration	Hormone involved in bone metabolism	Baseline
Secondary	Estradiol concentration	Hormone involved in bone metabolism	Baseline
Secondary	Insulin like growth factor-1 concentration	Hormone involved in bone metabolism	Baseline
Secondary	Sclerostin concentration	Hormone involved in bone metabolism	Baseline
Secondary	Adiponectin concentration	Hormone involved in bone metabolism	Baseline
Secondary	Leptin concentration	Hormone involved in bone metabolism	Baseline
Secondary	Body composition measured as visceral and subcutaneous adipose tissue	Measured by computed tomography (CT)	Baseline
Secondary	Body composition measured by fat and lean mass	Measured using dual-energy X-ray absorptiometry (DXA)	Baseline
Secondary	Bone marrow adiposity	Measured by computed tomography (CT)	Baseline
Secondary	Upper extremity muscle strength measured by grip force in kg	Measured using Jamar Hydraulic Hand Dynamometer	Baseline
Secondary	Lower extremity muscle strength measured by peak torque generated by knee extension	Measured using Biodex isokinetic dynamometer	Baseline
Secondary	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.	Baseline
Secondary	Functional exercise capacity measured by total distance ambulated during a 6 minute time period	Measured using Six Minute Walk Test	Baseline
Secondary	Self-reported physical activity measured in metabolic equivalents (MET)	Measured using the International Physical Activity Questionnaire	Baseline
Secondary	Cutaneous Advanced glycation end products (AGEs) measurement	Measured by measured by AGE Reader	Baseline
Secondary	Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days	Actigraph GT3X+ Accelerometer	Baseline
Secondary	Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities	Fullerton Advanced Balance (FAB) Scale	Baseline
Secondary	Physical health	SF-12	Baseline
Secondary	Community Participation Restriction	Life-space mobility assessment	Baseline
Secondary	Health-related quality of life	How are you today? Visual analogue scale	Baseline