Insulin Resistance in Pulmonary Arterial Hypertension
This study has been terminated.
(difficulty in finding eligible subjects)
Information provided by (Responsible Party):
Roham T. Zamanian, Stanford University
First received: January 16, 2009
Last updated: February 13, 2017
Last verified: February 2017
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.
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Treatment
||The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension
Primary Outcome Measures:
Secondary Outcome Measures:
| Study Start Date:
| Study Completion Date:
| 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
The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension ,is a study evaluating the incidence of insulin resistance in patients with pulmonary hypertension and testing the utility of a validated PH therapy(Tracleer) versus Pioglitazone in the treatment of those patients found to have insulin resistance.Patients with PAH must be stable on therapy for at least 3 months are considered for enrollment in this study.With the exception of PAH, subjects must be free of major medical illnesses, including diabetes mellitus ,malignancy or significant hepatic or renal disease.
|Ages Eligible for Study:
||18 Years to 75 Years (Adult, Senior)
|Sexes Eligible for Study:
|Accepts Healthy Volunteers:
Patients with Pulmonary Arterial Hypertension (PAH) must be stable on therapy for at least 3 months prior to enrollment in the trial. We will include patients with idiopathic PAH and Familial PAH as well as PAH associated with collagen vascular disease or drug or toxin exposure. With the exception of PAH, subjects must be free of major medical illnesses, including diabetes mellitus (must have fasting plasma glucose < 126 mg/dL and taking no anti-hyperglycemic agent), malignancy or significant hepatic or renal disease. Subjects may be hypertensive and on anti-hypertensive medications as long as blood pressure is < 150/100 mm Hg. Subjects may also be dyslipidemic and/or taking drugs to improve abnormalities of lipid metabolism, but they will be excluded if they are taking medications known to alter insulin sensitivity, including glucocorticoids, niacin, anti-retrovirals, thiazolidinediones, or metformin. Use of oral contraceptives or estrogen and/or progesterone replacement therapy is permitted. Weight must be stable and the subjects agree not to change their eating habits or exercise regimen during the study period. There will be no restrictions with regard to race or socioeconomic status, and the racial/ethnic composition of the study population will be reflective of the communities surrounding the Stanford University Medical Center.
* Vulnerable subject status.
- Concurrent Endothelin-1 antagonist therapy
- Concurrent Thiazolidinedione therapy
- New York Heart Class III or IV
- PAH related to other etiologies.
- Diabetes Mellitus with Fasting Glucose Levels > 126 mg/dL
- Allergy or hypersensitivity to pioglitazone or bosentan administration.
- Current treatment with statin therapy.
- Initiation of PAH therapy (prostacyclin analogues, phosphodiesterase-5 inhibitors) within three months of enrollment.
- Inability or unwillingness to avoid systemic steroid containing medications for four months. Inhaled steroid use is acceptable.
- Current or recent use or planned treatment with: glyburide, cyclosporine, nilotinib, nisoldipine, ranolazine, thioridazine
- Hepatic transaminases > 2x the upper limit of normal at the center at screening.
- Current or recent (< 6 months) chronic heavy alcohol consumption.
- Current use of another investigational drug (non-FDA approved) for PAH.
- Lung transplant recipients.
- History of myositis.
- Renal failure (Cr 2.0).
- Hospitalized or acutely ill.
- Chronic liver disease (cirrhosis, chronic hepatitis, etc.).
- Abnormalities of the arm or hand or radical mastectomy (preventing brachial artery ultrasound).
- Pregnant or lactating women.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00825266
|Stanford University School of Medicine
|Stanford, California, United States, 94305 |
||Roham T. Zamanian
||Roham T. Zamanian, Principle Investigator, Stanford University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 16, 2009
|Results First Received:
||November 21, 2016
||February 13, 2017
Keywords provided by Roham T. Zamanian, Stanford University:
pulmonary hypertension & insulin resistance
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 23, 2017
Familial Primary Pulmonary Hypertension
Glucose Metabolism Disorders
Respiratory Tract Diseases
Physiological Effects of Drugs
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action