Understanding Muscular Deficits of Diabetic Myopathy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Baseline: Evaluating the presence of sarcopenia in relation to the presence of hyperglycemia and/or obesity
研究概览
简要总结
The goal of this observational study is to assess if diabetes and obesity are independently related to functional and structural muscle deficits, and how muscular deficits relate to metabolic properties of diabetes and obesity. All studies will include clinical muscle strength and contractile examinations, functional tests, and MR imaging and spectroscopy techniques.
The main questions this project aims to answer are:
- Is chronic hyperglycemia in type 1 and 2 diabetes associated with functional and structural deficits of skeletal muscles unrelated to the presence of neuropathy?
- Is obesity associated with functional and structural impairments of skeletal muscles unrelated to the presence of type 2 diabetes ?
- Does weight loss improve muscle metabolic flexibility and economy and modify skeletal muscle function and structure in obese subjects with and without type 2 diabetes?
The project will include three studies, intended to answer the hypotheses listed above:
Study 1: Evaluation of functional and structural muscular deficits of diabetic myopathy in relation to prolonged hyperglycemia prior to and 6 months following glycemic improvement in patients with type 1 and 2 diabetes
Study 2: Functional and structural muscular deficits in severely obese subjects with and without type 2 diabetes prior to assisted weight loss.
Study 3: Changes in functional and structural muscle properties following assisted weight loss in severely obese subjects with and without type 2 diabetes - a 1-year follow-up study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-60 years
- •BMI: 18.5 - 39, minimum weight = 50kg
- •Chronic hyperglycemia: HbA1c of ≥ 70 mmol/mol with a duration of ≥ 2 months prior to enrollment
- •Physical activity: Less than 3 x 60 min of structured physical activity per week
- •Study 2 & 3:
- •Age: 25-60 years
- •BMI: ≥ 35
- •Physical activity: Less than 3 x 60 min of structured physical activity per week
- •Healthy Control Participants:
- •Age: 18-60 years
- •BMI: 18.5 - 30, minimum weight = 50kg
- •Physical activity: Less than 3 x 60 min of structured physical activity per week
排除标准
- •Study 1, 2, 3 and healthy controls:
- •Diabetic neuropathy with expected motor deficits
- •Uncontrolled cardiovascular or pulmonary disease, peripheral vascular disease, osteoarthropathy of the lower extremity, or any neurological og rheumatological disease which may affect muscle function, as well as any other disease that may effect ones ability to perform physical activity.
- •Any Magnetic Resonance contraindications
- •Any condition that by the principal investigator is expected to affect the participants ability to execute the study elements
- •Specifically for healthy control participants:
- •The presence of diabetes or pre-diabetes (HbA1c ≥42 mmol/mol)
研究组 & 干预措施
Non-obese participants with dysregulated type 1 diabetes
干预措施: 6-months of medically assisted glycemic improvement (Drug)
Non-obese participants with dysregulated type 2 diabetes
干预措施: 6-months of medically assisted glycemic improvement (Drug)
Obese participants with type 2 diabetes
干预措施: Bariatric surgery (Procedure)
Obese participants without type 2 diabetes
干预措施: Bariatric surgery (Procedure)
结局指标
主要结局
Baseline: Evaluating the presence of sarcopenia in relation to the presence of hyperglycemia and/or obesity
时间窗: The prevalence of sarcopenia in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline
The presence of sarcopenia is assessed based on recommended methods including measures of muscle strength (Biodex Dynamometer), muscle quantity and quality (MRI), and physical performance tests.
Baseline: Skeletal muscle Force-velocity assessment in relation to the presence of hyperglycemia and/or obesity
时间窗: The force-velocity relationship in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline
Assessed by isokinetic knee-extension and dorsal flexion on a Biodex Dynamometer at increasing angular-velocities
Baseline: Assessment of skeletal muscle fatigue in relation to the presence of hyperglycemia and/or obesity
时间窗: Fatigue in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline
Assessed by a fatiguing isotonic protocol for knee-extension and dorsal flexion on a Biodex Dynamometer including twitch-parameters of knee-extensors
Changes in skeletal muscle fatigue in relation to weight-loss or glycemic improvement
时间窗: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Changes in skeletal muscle force-velocity relationship with weight-loss or glycemic improvement
时间窗: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
Changes in parameters defining sarcopenia in relation to weight-loss or glycemic improvement
时间窗: Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3
次要结局
- 31P MRS: Skeletal muscle bioenergetics and metabolic economy(Bioenergetics and metabolic economy in participants with diabetes and hyperglycemia (study 1) or obesity (study 2) as compared to healthy control participants at baseline)
- 31P MRS: Changes of skeletal muscle bioenergetics and metabolic economy in relation to weight-loss or glycemic improvement(Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3)
- ENG assessment of neuropathic changes(Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3)
- Correlation analyses of primary measures with metabolic parameters including insulin resistance, HbA1c, metabolic economy, bioenergetics, and low-grade systemic inflammation (hs-CRP)(Change from baseline to follow-up at an average of 6 months for study 1 and 12 months for study 3)