Phase 4 Completed N=36 Randomized Quadruple-blind Prevention

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

Diabetes

Source: ClinicalTrials.gov NCT00770367 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2010

Primary outcomePrimary: Asymmetric Dimethylarginine (ADMA) Level — .80; .75 umol/L — p=.37

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).

Outcome Measures

Outcome	Result	p-value
PRIMARY Asymmetric Dimethylarginine (ADMA) Level	.80; .75	.37
SECONDARY NOx f2-isoprostanes	-1.4; -1	—

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT00770367). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.