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ClinicalTrials.gov Identifier: NCT03452267
Recruitment Status :
(Lack of funding)
First Posted : March 2, 2018
Last Update Posted : October 8, 2020
Wayne State University
Information provided by (Responsible Party):
Kyle Jon Burghardt, Pharm.D., Wayne State University
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.