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Insulin Resistance in Pulmonary Arterial Hypertension

This study has been terminated.
(difficulty in finding eligible subjects)
Information provided by:
Stanford University Identifier:
First received: January 16, 2009
Last updated: July 22, 2011
Last verified: July 2011
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.

Condition Intervention Phase
Hypertension, Pulmonary
Drug: bosentan
Drug: Pioglitigone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
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

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Insulin Resistance Profile Change

Secondary Outcome Measures:
  • 6 minute walk test
  • NYHA classification changes

Enrollment: 2
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bosentan
Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.
Drug: bosentan
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.
Drug: Pioglitigone
Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.
Other Name: Actos


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Patients with PAH must be stable on therapy for at least 3 months prior to enrollment in the trial. We will include patients with IPAH and FPAH 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.

Exclusion Criteria:

* Vulnerable subject status.

  • Concurrent ET-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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00825266

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Roham T. Zamanian Stanford University
  More Information

Responsible Party: Roham Zamanian, Stanford University Identifier: NCT00825266     History of Changes
Other Study ID Numbers: SU-09052008-1295
Study First Received: January 16, 2009
Last Updated: July 22, 2011

Keywords provided by Stanford University:
pulmonary hypertension & insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Familial Primary Pulmonary Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Lung Diseases
Respiratory Tract Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Antihypertensive Agents
Endothelin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action processed this record on March 24, 2017