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Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
Sponsor: Vanderbilt University Medical Center
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).
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
73
Start Date
2018-08-23
Completion Date
2025-08-19
Last Updated
2026-09-16
Healthy Volunteers
No
Conditions
Interventions
Metformin
Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.
Placebo
A treatment with no active ingredients or therapeutic effect.
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.
Usual Care
Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.
Locations (1)
Vanderbilt University Medical Center
Nashvile, Tennessee, United States