CompletedPhase 2

Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

United States73 participantsStarted 2018-08-23

Plain-language summary

The primary objective of this study is to determine the impact of two interventions against insulin resistance on the composite endpoint of 10% improvement in baseline six minute walk distance or improvement in World Health Organization (WHO) functional class in humans with pulmonary artery hypertension (PAH).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:• Adults aged 18 or older. * Diagnosed with idiopathic, heritable, or drug- or toxin-associated pulmonary arterial hypertension (PAH) according to World Health Organization consensus recommendations. * Stable PAH-specific medication regimen for three months prior to enrollment. Subjects with only a single diuretic adjustment in the prior three months will be included. Adjustments in IV prostacyclin for side effect management are allowed. * Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan. * WHO Functional Class I-III * Ambulatory Exclusion Criteria: * Prohibited from normal activity due to wheelchair bound status, bed bound status, reliance on a cane/walker, activity-limiting angina, activity-limiting osteoarthritis, or other condition that limits activity * Pregnancy * Diagnosis of PAH etiology other than idiopathic, heritable, or associated with drugs or toxins * FEV1\> or = 65% predicted AND normal chest imaging * WHO Functional class IV heart failure * Requirement of \> 1 diuretic adjustment in the prior 30 days * Preferred form of activity is not measured by an activity tracker (swimming, ice skating, stair master, or activities on wheels such as bicycling or rollerblading) * Type I diabetes mellitus * Prior diagnosis of cirrhosis * Untreated hypo- or hyper-thyroidism * estimated glomerular filtration rate (eGFR) by modification of diet in renal disease (MDRD) \<60 millili…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change From Baseline in Six Minute Walk Distance (Meters)

Timeframe: baseline and 12 weeks

Change From Baseline to Week 12 in World Health Organization Functional Class (WHO FC)

Timeframe: baseline and 12 weeks

Trial details

NCT IDNCT03617458

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-09

Results submitted2024-09-12

View on ClinicalTrials.gov More Pulmonary Artery Hypertension trials