NCT00770367

Brief Summary

SPECIFIC AIMS

  1. 1.To determine whether pioglitazone will reduce levels of asymmetric dimethylarginine(ADMA) in patients with diabetes.
  2. 2.To determine whether nitric oxide(NOx) products are increased with pioglitazone treatment.
  3. 3.To determine whether pioglitazone reduces oxidative stress (F2-isoprostanes).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at below P25 for phase_4 diabetes

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
6 months until next milestone

Results Posted

Study results publicly available

November 18, 2010

Completed
Last Updated

August 31, 2018

Status Verified

December 1, 2011

Enrollment Period

1.2 years

First QC Date

October 9, 2008

Results QC Date

July 8, 2010

Last Update Submit

August 1, 2018

Conditions

Diabetes

Keywords

Cardiovascular riskbiological markers

Outcome Measures

Primary Outcomes (1)

  • Asymmetric Dimethylarginine (ADMA) Level

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

    3 months

Secondary Outcomes (1)

  • NOx f2-isoprostanes

    3 months

Study Arms (2)

Pioglitazone then Placebo

EXPERIMENTAL

18 volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take Pioglitazone for the first 12 week period of the study and then take the placebo for the final 12 weeks of the study.

Drug: Pioglitazone then Placebo

Placebo then Pioglitazone

EXPERIMENTAL

18 (other half of participants) volunteers that are Diabetic adults, 40-75 years that have higher ADMA levels as well as increased inflammation will take the placebo for the first 12 week period of the study and then take the Pioglitazone for the final 12 weeks of the study.

Drug: Placebo then Pioglitazone

Interventions

Pioglitazone then PlaceboDRUG

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.

Also known as: Actos, Glustin, Zactos
Pioglitazone then Placebo
Placebo then PioglitazoneDRUG

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.

Also known as: Actos, Glustin, Zactos
Placebo then Pioglitazone

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Family Medicine, MUSC

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dana King MD
Organization
Medical University of South Carolina
kingde@musc.edu
843-792-8112

Study Officials

  • Dana E King, MD

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

August 31, 2018

Results First Posted

November 18, 2010

Record last verified: 2011-12

Locations

US(1)