Marlene Rabinovitch
Insulin Resistance in Pulmonary Arterial Hypertension
Contact Information
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Brief
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.
Recruiting Status:
RecruitingStanford Recruiting Status:
RecruitingCondition(s):
Intervention(s):
- Drug: Bosentan
- Drug: Pioglitazone
Phase:
Phase 4Eligibility
Ages Eligible for Study:
18 years to 75 yearsGenders Eligible for Study:
Male and FemaleHealth of Volunteers:
People with the conditions listed in this trial can participate as controls.Key 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.
Key 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.
Additional Study Details
Official Title:
The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial HypertensionAnticipated start date:
9/16/2008Lead Sponsor:
Stanford UniversityInvestigator(s):
Study Type:
InterventionalPurpose:
TreatmentAllocation:
RandomizedMasking:
Double BlindControl:
noneAssignment:
Single GroupEndpoints:
Safety/EfficacyPrimary Outcomes:
- Insulin Resistance Profile Change
Secondary Outcomes:
- 6 minute walk test
- NYHA classification changes
Total Number to be Enrolled:
20Total Number to be Enrolled at Stanford:
20More Information
Secondary ID(s):
- IRB#7432
Locations & Contacts
Stanford Locations & Contacts:
Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305Non-Stanford Locations:
The Stanford website does not have any locations outside of Stanford listed for this trial. You may want to check clinicaltrials.gov for posible additional locations.
This listing was last updated:
2/18/2009PLEASE NOTE:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician please feel free to call the SHC Physician Referral Service at (800) 756-9000 or send an email.
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