Hypertension, PulmonaryPhase 2NCT00825266
Insulin Resistance in Pulmonary Arterial Hypertension
A Phase 2 study testing bosentan and Pioglitazone in people with Hypertension, Pulmonary, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension, Pulmonary
- What is being tested?
- bosentan and Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to May 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Official title: The Effect of Bosentan and Pioglitazone on 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.
Read the detailed description
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.
- Conditions
- Hypertension, Pulmonary
- Being tested
- bosentan, Pioglitazone
- Keywords
- pulmonary hypertension & insulin resistance
- Medical subject headings
- Hypertension, Pulmonary, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bosentanDrug
Also called Tracleer
Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study.
PioglitazoneDrug
Also called Actos
Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study.
| Study group | Role | What they receive |
|---|---|---|
| bosentan | Active comparator | Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily. Receives: Drug: bosentan |
| Pioglitazone | Active comparator | Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study. Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio
insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.
Measured: baseline and 16 weeks
Secondary outcomes (2)
6 Minute Walk Test
6 minute walk test measures the distance that a patient can walk on a flat, hard surface in a period of 6 minutes.It assess the disease severity of the subject at 16 week compared to the baseline.
Measured: Baseline and 16 weeks
NYHA (New York Heart Association Classification) Changes
New York Heart Classification(NYHA) changes measured at 16 weeks compared with baseline.
NYHA Classification:
NYHA class I:no symptoms and no limitation in ordinary physical activity NYHA class II:Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity NYHA class III:Marked limitation in activity due to symptoms, even during less-than-ordinary activity, NYHA class IV:Severe limitations. Experiences symptoms even while at rest. {Higher NYHA class represent worse symptoms}
Measured: Baseline and 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startSep 2008
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: difficulty in finding eligible subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hypertension, PulmonaryStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roham T. Zamanian, Stanford University
- Investigators
- Roham T. Zamanian, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825266
- Sponsor's protocol ID
- SU-09052008-1295
- Other IDs
- IRB#7432
- Status last verified
- Feb 2017
- First submitted
- 16 Jan 2009
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bosentan and Pioglitazone on Insulin Resistance in Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT00825266
- Acronym / sponsor ID
- SU-09052008-1295
- Conditions
- Hypertension, Pulmonary
- Keywords
- pulmonary hypertension & insulin resistance
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulty in finding eligible subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Jan 2009 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bosentan | Active comparator | Drug: bosentanBosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily. |
| Pioglitazone | Active comparator | Drug: PioglitazonePioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (21 listed)
- Vulnerable subject status.
- Concurrent Endothelin-1 antagonist therapy
- Concurrent Thiazolidinedione therapy
- New York Heart Class III or IV
- PAH related to other etiologies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bosentanAlso: TracleerBosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study. | Drug | bosentan |
| PioglitazoneAlso: ActosPioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study. | Drug | Pioglitazone |
Primary outcome
Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio
Time frame: baseline and 16 weeks
insulin resistance measured -triglyceride: HDL cholesterol ratio measures at 16 weeks compared with baseline.
2 secondary outcomes
6 Minute Walk Test
Time frame: Baseline and 16 weeks
NYHA (New York Heart Association Classification) Changes
Time frame: Baseline and 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roham T. Zamanian principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bosentan and Pioglitazone in people with Hypertension, Pulmonary, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Resistance Profile Change - Triglyceride:HDL Cholesterol Ratio (time frame: baseline and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2017.