Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT00765505
Eligibility Criteria:
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT00765505
Study Brief:
Protocol Section:
NCT00765505