Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT03617458
PHASE2

Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension

Sponsor: Vanderbilt University Medical Center

View on ClinicalTrials.gov

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

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.

Locations (1)

Vanderbilt University Medical Center

Nashvile, Tennessee, United States