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

Suzanne Morin40 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes Mellitus Diabetes Mellitus, Type 2 Obesity Body Weight

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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