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Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

NCT03617458 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2025-09-22

Study results available
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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).

Conditions

  • Pulmonary Artery Hypertension

Interventions

DRUG

Metformin

Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.

DRUG

Placebo

A treatment with no active ingredients or therapeutic effect.

DEVICE

mHealth Intervention

Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.

DEVICE

Usual Care

Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • The Cleveland Clinic

    collaborator OTHER

  • Vanderbilt University Medical Center

    lead OTHER

Principal Investigators

  • Anna R Hemnes, MD · Vanderbilt University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-23
Primary Completion
2023-09-09
Completion
2025-08-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03617458 on ClinicalTrials.gov