Trial Summary
What is the purpose of this trial?
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).
Research Team
AR
Anna R Hemnes, MD
Principal Investigator
Vanderbilt University Medical Center
Eligibility Criteria
This trial is for adults over 18 with pulmonary arterial hypertension (PAH) who are able to walk and have been on a stable PAH medication regimen. They must own a smartphone with Bluetooth and data plan. Excluded are those with severe liver disease, untreated thyroid issues, certain physical limitations, pregnancy, poor kidney function, specific lung function criteria or type I diabetes.Inclusion Criteria
Subjects must own a Bluetooth capable modern smartphone capable of receiving and sending text messages and an active data plan
My PAH medication has been the same for the last 3 months, except for one diuretic change.
I have been diagnosed with PAH due to unknown causes, genetics, or exposure to drugs/toxins.
See 3 more
Exclusion Criteria
Pregnancy
My lung function is good and my chest scans are normal.
I have Type I diabetes.
See 8 more
Treatment Details
Interventions
- Metformin (Biguanides)
- mHealth Intervention (Behavioural Intervention)
- Placebo (Drug)
- Usual Care (Behavioural Intervention)
Trial OverviewThe study tests if Metformin or an mHealth intervention can improve walking distance by 10% or WHO functional class in PAH patients compared to placebo/usual care. Participants will be randomly assigned to one of the interventions.
Participant Groups
4Treatment groups
Active Control
Placebo Group
Group I: Metformin + mHealth InterventionActive Control2 Interventions
Patients will receive active ingredient medicine with mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
Subjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po twice a day (BID) x 5 days, 500mg by mouth (po) three times a day (TID) x 5 days,1000mg po BID x 69 days (12 weeks total).
Group II: Metformin + Usual CareActive Control2 Interventions
Patient will receive active ingredient medicine with routine medical care.
Subjects will receive metformin 500mg. Patients will titrate the medication as follows: 500mg po daily x 5 days, 500mg po BID x 5 days, 500mg po TID x 5 days,1000mg po BID x 69 days (12 weeks total).
Group III: Placebo + mHealth InterventionPlacebo Group2 Interventions
Patient will receive non active medicine and the mHealth texting platform, which are messages designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
Group IV: Placebo + Usual CarePlacebo Group2 Interventions
Patient will receive non active medicine and routine medical care.
Metformin is already approved in Canada, Japan, China, Switzerland for the following indications:
Approved in Canada as Glucophage for:
- Type 2 diabetes
Approved in Japan as Glucophage for:
- Type 2 diabetes
Approved in China as Glucophage for:
- Type 2 diabetes
Approved in Switzerland as Glucophage for:
- Type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
Trials
922
Recruited
939,000+
The Cleveland Clinic
Collaborator
Trials
1,072
Recruited
1,377,000+
Mayo Clinic
Collaborator
Trials
3,427
Recruited
3,221,000+