Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

PHASE2CompletedINTERVENTIONAL
Enrollment

73

Participants

Timeline

Start Date

August 23, 2018

Primary Completion Date

September 9, 2023

Study Completion Date

August 19, 2025

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.

Trial Locations (1)

37232

Vanderbilt University Medical Center, Nashville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Mayo Clinic

OTHER

collaborator

The Cleveland Clinic

OTHER

lead

Vanderbilt University Medical Center

OTHER

NCT03617458 - Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension | Biotech Hunter | Biotech Hunter