This trial is testing two interventions to see if they can improve insulin resistance in people with pulmonary artery hypertension. The primary endpoint is a 10% improvement in the distance the person can walk in six minutes, or an improvement in the person's functional class according to the World Health Organization.
- Pulmonary Arterial Hypertension
2 Primary · 37 Secondary · Reporting Duration: baseline and 12 weeks
Awards & Highlights
4 Treatment Groups
Metformin + mHealth Intervention
1 of 4
Metformin + Usual Care
1 of 4
Placebo + mHealth Intervention
1 of 4
Placebo + Usual Care
1 of 4
130 Total Participants · 4 Treatment Groups
Primary Treatment: Metformin + mHealth Intervention · Has Placebo Group · Phase 2
Who is running the clinical trial?
Age 18+ · All Participants · 1 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- D'Alonzo, Gilbert E.. 1991. “Survival in Patients with Primary Pulmonary Hypertension”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/0003-4819-115-5-343.
- Mathai, Stephen C., Milo A. Puhan, Diana Lam, and Robert A. Wise. 2012. “The Minimal Important Difference in the 6-minute Walk Test for Patients with Pulmonary Arterial Hypertension”. American Journal of Respiratory and Critical Care Medicine. American Thoracic Society. doi:10.1164/rccm.201203-0480oc.
- Benza, Raymond L., Dave P. Miller, Robyn J. Barst, David B. Badesch, Adaani E. Frost, and Michael D. McGoon. 2012. “An Evaluation of Long-term Survival from Time of Diagnosis in Pulmonary Arterial Hypertension from the REVEAL Registry”. Chest. Elsevier BV. doi:10.1378/chest.11-1460.
- D'Alonzo GE, Barst RJ, Ayres SM, Bergofsky EH, Brundage BH, Detre KM, Fishman AP, Goldring RM, Groves BM, Kernis JT, et al. Survival in patients with primary pulmonary hypertension. Results from a national prospective registry. Ann Intern Med. 1991 Sep 1;115(5):343-9. doi: 10.7326/0003-4819-115-5-343.
- Anna Hemnes 2018. "Interventions Against Insulin Resistance in Pulmonary Arterial Hypertension". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03617458.
Frequently Asked Questions
Is the Metformin and mHealth Intervention combination a risk-free solution for patients?
"Despite no previous evidence of efficacy, the safety profile of Metformin + mHealth Intervention was rated a 2 due to some existing data indicating its security." - Anonymous Online Contributor
What objectives is this research endeavor attempting to accomplish?
"This clinical trial seeks to measure the efficacy of mHealth intervention or metformin in improving six minute walking distance and daily step count over a 12 week period. Secondary outcomes include an assessment of differences in participant characteristics including demographic information, current medication regimen, physical exam results, echocardiogram readings and laboratory values at baseline compared with those taken after completion of the treatment. Plasma Brain Natriuretic Peptide (BNP) will also be measured as it is a marker for myocardial stress which decreases with exercise training." - Anonymous Online Contributor
Is admission for participants currently available in this research program?
"According to clinicaltrials.gov, this research is still open for recruitment and has been regularly updated since it was first posted on August 23rd 2018. The most recent update occurred on June 27th 2022." - Anonymous Online Contributor
Has Metformin been combined with mobile health tools in past studies?
"Currently, 170 clinical trials studying the Metformin + mHealth Intervention are in operation. 43 of these investigations have progressed to Phase 3 and most them originate from Pittsburgh, Pennsylvania; though 1903 other medical sites are also conducting research into this therapy." - Anonymous Online Contributor
To what extent is participation in this medical experiment limited?
"Affirmative, the clinical trial remains open for enrollment. According to the data hosted on clinicialtrials.gov, this medical investigation was first posted on August 23rd 2018 and most recently updated on June 27th 2022; it is currently seeking 130 participants at a single location." - Anonymous Online Contributor
What conditions may be alleviated by the Metformin + mHealth Intervention combination?
"Metformin and a mHealth Intervention are two viable treatments for physical activity, type 1 diabetes mellitus, and diabetic ketoacidosis." - Anonymous Online Contributor