Determinants of Bone and Muscle Quality and Strength in Obesity With and Without Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Muscle size measured as cross-sectional muscle area at the proximal femur
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
结局指标
主要结局
Muscle size measured as cross-sectional muscle area at the proximal femur
时间窗: Baseline
Measured by quantitative computed tomography (QCT)
Muscle composition measured as muscle fat content at the proximal femur
时间窗: Baseline
Measured by quantitative computed tomography (QCT)
Volumetric bone mineral density (vBMD) at the spine, hip, radius and tibia
时间窗: Baseline
Measured by quantitative computed tomography (QCT)
次要结局
- N-terminal propeptide of type 1 procollagen concentration(Baseline)
- C-telopeptide concentration(Baseline)
- Insulin concentration(Baseline)
- Parathormone concentration(Baseline)
- Estradiol concentration(Baseline)
- Body composition measured as visceral and subcutaneous adipose tissue(Baseline)
- Upper extremity muscle strength measured by grip force in kg(Baseline)
- Lower extremity muscle strength measured by peak torque generated by knee extension(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.(Baseline)
- Functional exercise capacity measured by total distance ambulated during a 6 minute time period(Baseline)
- Sclerostin concentration(Baseline)
- Serum 25-hydroxyvitamin D concentration(Baseline)
- Fasting Hemoglobin A1c concentration(Baseline)
- Body composition measured by fat and lean mass(Baseline)
- Bone marrow adiposity(Baseline)
- Osteocalcin (total and decarboxylated) concentration(Baseline)
- Bone specific alkaline phosphatase concentration(Baseline)
- Fasting glucose concentration(Baseline)
- Cutaneous Advanced glycation end products (AGEs) measurement(Baseline)
- Insulin like growth factor-1 concentration(Baseline)
- Adiponectin concentration(Baseline)
- Leptin concentration(Baseline)
- Physical health(Baseline)
- Self-reported physical activity measured in metabolic equivalents (MET)(Baseline)
- Functional balance score obtained using multidimensional balance assessment. Higher scores indicate better balance abilities(Baseline)
- Physical activity measured by total activity and time spent in different intensities of exercise measured over 7 consecutive days(Baseline)
- Community Participation Restriction(Baseline)
- Health-related quality of life(Baseline)
研究者
Suzanne Morin
Clinician Researcher
McGill University Health Centre/Research Institute of the McGill University Health Centre