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Can a diabetes drug help PAH patients walk farther?

NCT ID NCT03617458

Symptom relief Sponsor: Vanderbilt University Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 2 times

Summary

This study tested whether metformin, a common diabetes drug, along with a text-message activity program, could help people with pulmonary artery hypertension (PAH) walk farther and feel better day-to-day. 73 adults with PAH took part. The goal was to see if these interventions improved walking distance or daily function over 12 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Metformin
What this could lead to
If successful, this could point toward a new way to ease symptoms and improve daily function for people with pulmonary artery hypertension.
What could go wrong
This is a small, early-phase trial with only 73 participants, so results may not apply to everyone. Metformin is generally safe but can cause stomach upset or rare side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

73 people

The number who actually took part.

Started

Aug 2018

Finished

Aug 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 milliliters per minute (mL/min)

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Conditions

The condition(s) this trial relates to.

drug- or toxin-induced pulmonary arterial hypertension Familial Primary Pulmonary Hypertension heritable pulmonary arterial hypertension idiopathic pulmonary arterial hypertension pulmonary arterial hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pulmonary artery hypertension

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashvile, Tennessee, 37232, United States

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