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

This study has been completed.

Study NCT00770367 Information provided by Medical University of South Carolina

First Received on October 9, 2008. Last Updated on December 2, 2011 History of Changes

Results First Received: July 8, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Diabetes
Interventions:	Drug: Pioglitazone then Placebo Drug: Placebo then Pioglitazone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
medical clinic, 36 participants recruited

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After informed consent, a laboratory specimen will be obtained at the visit, including a pregnancy test (if indicated), and the screening ADMA level. This information will be used to determine study eligibility. Screened participants will be eligible if their ADMA > 0.50 μM/L. If not eligible would be excluded from study.

Reporting Groups

	Description
Pioglitazone	This is the analysis period during which participants took Pioglitazone.
Placebo	The analysis period during which participant took the placebo.

Participant Flow for 3 periods

Period 1: First Intervention

	Pioglitazone	Placebo
STARTED	18	18
COMPLETED	18	16
NOT COMPLETED	0	2
Withdrawal by Subject	0	2

Period 2: Washout Period of 4 Weeks

	Pioglitazone	Placebo
STARTED	18	16
COMPLETED	18	15
NOT COMPLETED	0	1
Withdrawal by Subject	0	1

Period 3: Second Intervention

	Pioglitazone	Placebo
STARTED	18	15
COMPLETED	16	15
NOT COMPLETED	2	0
Lost to Follow-up	2	0

Baseline Characteristics

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Reporting Groups

	Description
Pioglitazone	This is the analysis period during which participants took Pioglitazone.
Placebo	The analysis period during which participant took the placebo.

Baseline Measures

	Pioglitazone	Placebo	Total
Number of Participants [units: participants]	18	18	36
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	18	18	36
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	52.2 ± 1.89	55.7 ± 2.42	54 ± 1.56
Gender [units: participants]
Female	7	8	15
Male	11	10	21
Region of Enrollment [units: participants]
United States	18	18	36

Outcome Measures

1. Primary:

Asymmetric Dimethylarginine (ADMA) Level [ Time Frame: 3 months ]

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2. Secondary:

NOx f2-isoprostanes [ Time Frame: 3 months ]

Results not yet posted. Anticipated Posting Date: 12/2010 Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Dana King MD
Organization: Medical University of South Carolina
phone: 843-792-8112
e-mail: kingde@musc.edu

No publications provided

Responsible Party:	Dana King, Medical University of South Carolina
ClinicalTrials.gov Identifier:	NCT00770367 History of Changes
Other Study ID Numbers:	Takeda 07-060, 18379
Study First Received:	October 9, 2008
Results First Received:	July 8, 2010
Last Updated:	December 2, 2011
Health Authority:	United States: Institutional Review Board