Muscle Lipid and Insulin Resistance in the Elderly (MIRA)
研究概览
详细说明
Hypothesis and Specific Aims:
To determine whether aerobic exercise improves both skeletal muscle fat distribution and insulin sensitivity of older men and women. We will test two hypotheses.
i. Physical exercise in older adults will decrease the amount of fat interspersed within muscle, specifically the fat between muscle groups (intermuscular adipose tissue) as well as decrease specific lipid metabolites within muscle cells, compared to controls.
ii. Exercise-induced improvements in insulin sensitivity of older men and women will be related to the changes in muscle fat content independent of changes in total body fat or visceral abdominal adipose tissue.
To determine whether increased capacity for oxidative fatty acid metabolism within muscle results in improved insulin sensitivity in older adults. We will test two hypotheses.
i. Exercise training will increase the capacity of muscle to oxidize fatty acids assessed both in vitro and in vivo.
ii. Improved capacity for oxidative fatty acid metabolism will predict improvements in insulin sensitivity.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15213
- University of Pittsburgh
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 60 - 70 years of age
- No weight gain/loss of >10 lbs in 6 months
- Sedentary (No more than 1 continuous exercise/week) or Highly trained (>5 exercise sessions/week for a duration of one year or more)
- Non-Smoker
- BMI 18-38.0
- Resting blood pressure less than 150mmHg systolic/95 mmHg diastolic
- Normal glucose tolerance: Fasting glucose < 100 mg/dl or 2 hour glucose from OGTT < 140 mg/dl or impaired glucose tolerance (fasting glucose > 100 mg/dl < 126 mg/dl or 2 hour glucose from OGTT > 140 mg/dl but less than 200 mg/dl
- Note from PCP/Cardiologist for exercise clearance if positive stress test symptoms were observed from GXT
Exclusion Criteria:
- Clinically significant CVD including h/o MI
- Peripheral Vascular Disease
- Hepatic, renal, muscular/neuromuscular, or active hematologic/oncologic disease
- Clinically diminished pulse
- Presence of bruits in lower extremities
- Previous history of pulmonary emboli
- Peripheral Neuropathy
- Currently not engaged in a regular program and have a V)2 max pre-training value > 55 ml/kg-fat free mass-min., indicative of moderate fitness OR currently engaged in regular program and having a V)2 max value < 55 ml/kg-fat free mass-min.
- Anemia (Hematocrit < 34%)
- Any contraindications to moderate exercise
- Inability and/or willingness to comply with the protocol as written
- Active alcohol or substance abuse (Past 5 years)
- Total cholesterol > 300 mg/dL
- Triglyceride > 350 mg/dL
- ALT > 80, AST > 80, Alk Phos > 240
- Proteinuria (defined as > 1+ on routine dipstick) hypothyroidism (sTSH>8)
- Therapeutic Doses of Nicotinic Acid
- Type 2 Diabetes: Fasting Glucose > 126 mg/dl or 2 hour glucose > 200 mg/dl
- Oral Glucocorticoids
- Females currently on hormone replacement therapy (HRT) less than 6 months
- Claustrophobia
- Previous difficulty with lidocaine or other local anesthetic
Stress test symptoms:
- Positive ECG (>2mm ST segment depression) without PCP cardiologist permission to participate
- Signs or symptoms of cardiovascular decomposition (hypotensive response to exercise
- Onset of angina or angina like symptoms, shortness of breath, change in heart rhythm, signs of poor perfusion (light-headedness), tightness
- Hypotension
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：1
Exercise Group
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Sixteen week intervention where subjects will be progressed to four days per week for 45 minutes per session, 180 minutes minimum per week, of moderate intensity supervised exercise.
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实验性的：Health Education Group
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Sixteen week intervention.
This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Insulin sensitivity and muscle fat content will be measured at the beginning and the end of the intervention to determine the effects of exercise on these measures.
大体时间：16 weeks
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16 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects.
大体时间：16 weeks
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16 weeks
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合作者和调查者
调查人员
- 首席研究员：Bret H. Goodpaster, PhD、University of Pittsburgh
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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