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Completed

NCT Number: NCT00770367

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

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).

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Family Medicine, MUSC

Charleston, South Carolina, 29425, United States

About this study

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 found that elevated serum ADMA is associated with increased cardiovascular events and mortality, particularly in people with diabetes (Boger 2005, Zoccali 2006, Ueda 2007). ADMA, by mediating nitric oxide (NO) availability, may trigger pro-atherogenic effects. High plasma concentration of this substance has been associated with intima-media thickening, left ventricular hypertrophy and all-cause and cardiovascular mortality in patients with end-stage renal disease, and associated with increased cardiovascular events in patients with diabetes (Kryzazanowska 2007). The result of higher levels of ADMA and reduced output of NO increases vasoconstriction, increases inflammation, and interferes with endothelial function. Preliminary studies indicate that pioglitazone may reduce ADMA levels, and thus lower cardiovascular risk.Thus, this protocol will test whether pioglitazone can reduce ADMA levels in adult patients with diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pioglitazone then Placebo

Drug

Subjects will take the pioglitazone 30mg tablet daily for 3 months. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take a placebo.

Other names: Actos, Glustin, Zactos

Placebo then Pioglitazone

Drug

Subjects will take the placebo for the first 12 weeks of the study. This will be followed by a 4-week period during which subjects will not be taking either the study drug or placebo. During the final 12-week period the group will take the pioglitazone 30mg tablet daily for 3 months.

Other names: Actos, Glustin, Zactos

Primary outcomes

  1. Asymmetric Dimethylarginine (ADMA) Level

    Time frame: 3 months

    Labs measured micro moles per liter of ADMA levels in participants.

Secondary outcomes

  1. NOx f2-isoprostanes

    Time frame: 3 months

    Measured oxidative stress - NOx measured by chemiluminescence detection using the Sievers NOA 280i and f2-isoprostanes are isolated by thin layer chromatography and subjected to a highly sensitive and specific gas chromatography/mass spectroscopy method to measusre the oxidative stress

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • Takeda Pharmaceuticals North America, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Oct 10, 2008
Registry last updated
Aug 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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