Skeletal Muscle Lipid and Insulin Resistance: Effects of Physical Activity and Weight Loss

Completed · Not applicable

Conditions studied: Type 2 Diabetes Mellitus

In brief

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 progression of type 2 diabetes. The investigators predict that insulin sensitivity will improve equally following either weight loss or exercise, while there will be additive effects from combined intervention. The investigators hypothesize that weight loss will decrease intermuscular adipose tissue, intramyocellular lipid, and visceral abdominal adipose tissue.

Key facts

Study ID

NCT00766298

Run by

University of Pittsburgh

People needed

102

Starts

2004-06-01

Expected to finish

2011-08-01

Last updated by the study team

2017-07-31

Who can join

Age: 60 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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,

Where it is running

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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