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The insulin sensitizing effects of metformin and pioglitazone in the skeletal muscle remain unknown. Our group aims to analyze molecular changes within the skeletal muscle of pre-diabetic patients through the use of a clinical trial in humans.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Pre-diabetes as defined by an oral glucose tolerance test 2-hour level between 140 and 200 mg/dL
General Inclusion Criteria:
Able to communicate meaningfully with the investigator and legally competent to provide informed written consent.
Female subjects must be non-lactating, have a negative pregnancy test, and be on acceptable birth control.
Oral glucose tolerance test <140 or >200mg/dL
Treated with any of the following medications:
Systemic glucocorticoids (more than 2 weeks), antineoplastic agents, transplant medications, fibrates, anti-retroviral medications, or thiazolidinediones within 6 months prior to screening
Start or change of hormonal replacement therapy within 3 months prior to screening
Short-acting insulin (more than15 units per day) in DMT2 subjects, indicating severe insulin deficiency within 6 months prior to screening
History or presence of any of the following conditions:
Clinically significant heart disease (New York Heart Classification greater than grade II; more than non-specific ST-T wave changes on the EKG)
Peripheral vascular disease (history of claudication)
Clinically significant pulmonary disease.
Current uncontrolled hypertension (systolic BP>160 mmHg, diastolic BP>100 mmHg)
History or presence of malignancy other than basal cell or squamous cell skin cancer
Clinically significant hematologic disease
Any of the following abnormal laboratory values:
Hematocrit < 35 vol%
Serum creatinine > 1.6 mg/dl
AST, ALT or Alkaline phosphatase > 2.5 times the upper limit of normal
PT, PTT outside the normal reference range
TSH outside the normal reference range
Triglycerides > 400 mg/dl
Platelet count < 50,000
Current or history of drug abuse or alcohol abuse
Blood donation within 2 months prior to screening
Engage in exercise with moderate to hard intensity for greater than 1 hour per day for 5 or more days per week.