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

Suzanne Morin

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT04093856

MP-37-2020-5872

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

40 participants in 2 patient groups

Diabetic

Description:

20 men and women with type 2 diabetes and obesity

Non-diabetic

Description:

20 normoglycemic men and women with obesity matched for age and sex with diabetic group