Ignite Creation Date:
2024-05-06 @ 10:32 AM
Last Modification Date:
2024-10-26 @ 12:31 PM
Study NCT ID:
NCT03288025
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-08
First Post:
2017-08-31
Brief Title:
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise PHINE
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Pulmonary Arterial Hypertension Improvement With Nutrition and Exercise PHINE A Randomized Controlled Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL130209 | NIH | None | httpsreporternihgovquickSearchR01HL130209 |