Insulin Resistance in Pulmonary Arterial Hypertension
The purpose of this study is to evaluate 1) the incidence of insulin resistance (a pre-diabetic state) in patients with pulmonary hypertension, and 2) test the utility of a validated PH therapy (Tracleer) versus Pioglitazone in the treatment of those patients found to have insulin resistance.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension|
- Insulin Resistance Profile Change
- 6 minute walk test
- NYHA classification changes
|Study Start Date:||September 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||May 2010 (Final data collection date for primary outcome measure)|
Active Comparator: bosentan
Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.
Other Name: Tracleer
Active Comparator: Pioglitazone
Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.
Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.
Other Name: Actos
Please refer to this study by its ClinicalTrials.gov identifier: NCT00825266
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Roham T. Zamanian||Stanford University|