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Insulin Resistance in Pulmonary Arterial Hypertension

This study has been terminated.
(difficulty in finding eligible subjects)
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00825266
First received: January 16, 2009
Last updated: July 22, 2011
Last verified: July 2011
  Purpose

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
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825266

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

No publications provided

Responsible Party: Roham Zamanian, Stanford University
ClinicalTrials.gov Identifier: NCT00825266     History of Changes
Other Study ID Numbers: SU-09052008-1295, IRB#7432
Study First Received: January 16, 2009
Last Updated: July 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
pulmonary hypertension & insulin resistance

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Insulin Resistance
Cardiovascular Diseases
Glucose Metabolism Disorders
Hyperinsulinism
Lung Diseases
Metabolic Diseases
Respiratory Tract Diseases
Vascular Diseases
Bosentan
Insulin
Pioglitazone
Antihypertensive Agents
Cardiovascular Agents
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014