Muscle Lipid and Insulin Resistance in the Elderly (MIRA)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Pennsylvania
-
Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：1
Exercise Group
|
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.
|
|
実験的：Health Education Group
|
Sixteen week intervention.
This group will not receive specific exercise education or prescription but will be asked to participate in biweekly health education sessions
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
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.
時間枠：16 weeks
|
16 weeks
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Examine if exercise-induced improvements in insulin sensitivity are similar in normal weight and in obese older subjects.
時間枠：16 weeks
|
16 weeks
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Bret H. Goodpaster, PhD、University of Pittsburgh
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。