Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE)
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|ClinicalTrials.gov Identifier: NCT03288025|
Recruitment Status : Recruiting
First Posted : September 19, 2017
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Arterial Hypertension Insulin Resistance||Behavioral: Nutrition and Exercise||Not Applicable|
Pulmonary arterial hypertension (PAH) leads to premature death as a consequence of increased pulmonary vascular resistance and right heart failure. PAH-targeted therapies developed over the past 20 years target excessive vasoconstriction. However, the pathobiology of PAH is more complicated, and includes dysregulated vascular cell proliferation, cellular metabolic abnormalities, and inflammation. Even with modern PAH therapies, current outcomes remain poor, with an estimated 3-year survival rate of only 55%. Thus, there is a clear need for more effective therapies, based on better understanding of the pathobiology of the disease.
Insulin resistance has emerged as a potential new mechanism in PAH. Animal models of insulin resistance are associated with PAH, which reverses with the administration of insulin sensitizing drugs. Over the past decade there has been an epidemiologic shift in PAH, where the disease is increasingly observed in older, obese, and diabetic subjects. Low levels of high-density lipoprotein cholesterol in PAH, a feature of insulin resistance, have been observed and found to be a strong independent predictor of PAH mortality. Elevated glycosylated hemoglobin (HbA1c) also correlates with PAH diagnosis and severity. As measured by the OGTT, idiopathic PAH patients have not only insulin resistance, but also an inability to mount an appropriate insulin response to a glucose challenge. These data point to dysfunction in the pancreatic beta cells of PAH patients. It is known that an exercise and low glycemic index diet intervention improves insulin sensitivity in pre-diabetic subjects.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise (PHINE) A Randomized Controlled Trial|
|Actual Study Start Date :||September 27, 2017|
|Estimated Primary Completion Date :||December 28, 2022|
|Estimated Study Completion Date :||December 28, 2023|
Experimental: Nutrition and Exercise
5 days a week of moderate exercise and biweekly diet counseling on Low Glycemic Index/ Mediterranean Diet for 12 weeks.
Behavioral: Nutrition and Exercise
5 times a week exercise training and biweekly diet counseling for 12 weeks.
No Intervention: Standard of Care
Counseling at baseline on diet as recommended by USDA and on the benefits of regular aerobic exercise.
- Insulin Sensitivity [ Time Frame: 5 years ]Assessed by the frequently-sampled intravenous glucose tolerance test. Units of assessment in min/uU*mL
- Right Ventricular Global Peak Longitudinal Strain [ Time Frame: 5 years ]Assessed by the Doppler Echocardiography 2D longitudinal speckle tracking. Units of assessment in percent.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03288025
|Contact: Chazity Bushemail@example.com|
|Contact: Gustavo Heresi||216-636-5327||HERESIG@ccf.org|
|United States, Ohio|
|Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Chazity Bush 216-444-3702 firstname.lastname@example.org|
|Principal Investigator: Raed Dweik|
|Principal Investigator: Gustavo Heresi|
|Sub-Investigator: John Kirwan|
|Principal Investigator:||Raed Dweik||The Cleveland Clinic|
|Principal Investigator:||Gustavo Heresi||The Cleveland Clinic|