At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension
In Brief
A Phase 2 clinical trial evaluating Metformin, Placebo, and 2 other interventions for Pulmonary Artery Hypertension. Completed, enrolled 73 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.
A treatment with no active ingredients or therapeutic effect.
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.
Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.