Status:
COMPLETED
Pioglitazone and Serum Asymmetric Dimethylarginine (ADMA) in Patients With Diabetes
Lead Sponsor:
Medical University of South Carolina
Collaborating Sponsors:
Takeda Pharmaceuticals North America, Inc.
Conditions:
Diabetes
Eligibility:
All Genders
40-75 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The primary purpose of this study is to determine whether treatment with pioglitazone can reduce serum levels of asymmetric dimethylarginine (ADMA) in patients with adult diabetes. Recent research has...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00770367
Start Date
October 1 2008
End Date
June 1 2010
Last Update
August 31 2018
Active Locations (1)
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1
Department of Family Medicine, MUSC
Charleston, South Carolina, United States, 29425