Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes

Completed · Phase 4 · Has a placebo group

Conditions studied: Diabetes

In brief

SPECIFIC AIMS 1. To determine whether pioglitazone will reduce levels of asymmetric dimethylarginine(ADMA) in patients with diabetes. 2. To determine whether nitric oxide(NOx) products are increased with pioglitazone treatment. 3. To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).

Key facts

Study ID

NCT00770367

Run by

Medical University of South Carolina

People needed

36

Starts

2008-10-01

Expected to finish

2010-06-01

Last updated by the study team

2018-08-31

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults age 40--75 years-of-age, non-pregnant
• Informed consent
• History of type 2 Diabetes Mellitus
• Stable weight for the last 3 months (no change greater than +5% of body weight)
• ADMA > 0.50 µM/L (mean of non-diabetic reference group) (Devangelio 2007)
• On stable medical therapy for at least 3 months
• A working telephone

You may not qualify if…

• Any history of known coronary heart disease, including a history of congestive heart failure, myocardial infarction, coronary re-vascularization, or stroke
• Pregnancy
• Chronic kidney disease, serum creatinine >2.0mg/dl, chronic liver disease, or uncontrolled hypertension (>160/100).
• Current participation in a formal weight loss program or planning to start such a program during the next 3 months
• Collagen vascular disease, infection, or other inflammatory condition
• Electrocardiogram (EKG) evidence of ischemia or infarction
• Macular edema (swelling of the back of the eye), recent excessive weight gain (over 5% of weight in 30 days), elevated liver function tests > 2.5 X the upper limit, or history of osteoporosis

Where it is running

• Department of Family Medicine, MUSC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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