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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana King; Medical University of South Carolina
• Collaborator: Takeda Pharmaceuticals North America, Inc.
• Treatments: N,N-dimethylarginine; Pioglitazone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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