Status:
COMPLETED
Skeletal Muscle Lipid and Insulin Resistance: Effects of Physical Activity and Weight Loss
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
American Diabetes Association
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
60-75 years
Phase:
NA
Brief Summary
102 late- life adults at risk for developing type 2 diabetes mellitus, will be randomized to one of three interventions designed to improve insulin sensitivity thereby potentially preventing future pr...
Detailed Description
The primary objective of this project will be to examine the role of skeletal muscle lipid and capacity for fat oxidation in insulin resistance in older adults who either are at high risk for the deve...
Eligibility Criteria
Inclusion
- 60-75 years of age
- Stable weight (No Gain/Loss of \> 10 lbs in 6 months)
- Impaired Glucose Tolerance or Newly, untreated, undiagnosed type 2 diabetes
- Sedentary
- Non-smoker
- BMI 25.0-38.0 KG/M2
- Resting Blood Pressure ≤ 150mmHg systolic and ≤ 95 mmHg diastolic
- IGT: Fasting Glucose \> 100, \< 126 2-Hour OGTT \> 140 but \< 200
- T2D: Fasting Glucose \> 126 \< 2000 2-Hour OGTT \> 200
- Note from PCP/Cardiologist for exercise clearance if positive stress test symptoms were observed from GXT
Exclusion
- 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 VO2 max pre-training value \> 55 ml/kg-fat free mass-min., indicative of moderate fitness.
- Anemia (Hematocrit \< 34%)
- Any contraindications to moderate exercise (Please specify)
- Inability and/ or unwillingness 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00766298
Start Date
June 1 2004
End Date
August 1 2011
Last Update
July 31 2017
Active Locations (1)
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1
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213