Fact CheckerSign in

NCT03617458CompletedPhase 2

Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
73 (actual)
First submitted
2 May 2018
Start date
23 Aug 2018
Primary completion date
9 Sept 2023
Lead sponsor
Vanderbilt University Medical Center
NCT number
NCT03617458

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 73
  • From 23 Aug 2018 to the primary completion date, 9 Sept 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Diagnosis of PAH etiology other than idiopathic, heritable, or associated with drugs or toxins
  • Requirement of \> 1 diuretic adjustment in the prior 30 days
  • Prior diagnosis of cirrhosis

Other illness

  • 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
  • WHO Functional class IV heart failure
  • Type I diabetes mellitus

Lab values

  • estimated glomerular filtration rate (eGFR) by modification of diet in renal disease (MDRD) \<60 milliliters per minute (mL/min)

Other

  • Pregnancy
  • FEV1\> or = 65% predicted AND normal chest imaging
  • 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)
  • Untreated hypo- or hyper-thyroidism

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Vanderbilt University Medical Center
Coordinator of this site? Confirm its status		NashvileUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.