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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03288025
Other study ID # 16-260
Secondary ID R01HL130209
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 27, 2017
Est. completion date June 30, 2024

Study information

Verified date January 2024
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the extent to which diet and exercise may improve PAH through the modulation of insulin sensitivity. The central hypothesis is that dysregulated glucose metabolism elicits a response in PAH patients that can be modified by exercise and diet, thereby leading to improvements in pulmonary vascular disease.


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 34
Est. completion date June 30, 2024
Est. primary completion date February 18, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Age range between 18-75 years old - Group 1 PAH, including idiopathic, heritable, drugs and toxin induced, and PAH associated with connective tissue disease, HIV infection and congenital heart disease - NYHA Class II or III - = 1 PAH-targeted therapy with a stable dose for = 2 months - Stable dose of diuretics and rate of supplemental oxygen for the preceding 2 months Exclusion Criteria: - Decompensated Right Heart Failure - NYHA Class IV - Syncope within the previous 3 months - Cardiac Arrhythmia (except for controlled atrial fibrillation or flutter) - Baseline supplemental O2 > 4 LPM - Portal Hypertension - Pulmonary hypertension due to Lung Disease and Hypoxia - Pulmonary Hypertension due to Left Heart Disease - Chronic Thromboembolic Pulmonary Hypertension - Pulmonary Hypertension associated with systemic diseases such as hematological disorders and sarcoidosis - Type 2 Diabetes - Evidence of cardiac ischemia on a graded exercise test

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Nutrition and Exercise
5 times a week exercise training and biweekly diet counseling for 12 weeks.

Locations

Country Name City State
United States Cleveland Clinic Foundation Cleveland Ohio

Sponsors (2)

Lead Sponsor Collaborator
The Cleveland Clinic National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Insulin Sensitivity Assessed by the frequently-sampled intravenous glucose tolerance test. Units of assessment in min/uU*mL 5 years
Secondary Right Ventricular Global Peak Longitudinal Strain Assessed by the Doppler Echocardiography 2D longitudinal speckle tracking. Units of assessment in percent. 5 years
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