Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04055428
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2019-08-07
Brief Title:
NAUTICAL Effect of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals NAUTICAL
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Black individuals are more likely to have decreased insulin sensitivity which results in a high risk for the development of cardiometabolic disease The reasons for this are incompletely understood Natriuretic peptides NPs are hormones produced by the heart that play a role in regulating the metabolic health of an individual Low circulating level of NPs is an important contributor to increased risk for diabetes The NP levels are relatively lower among Black individuals thus affecting their metabolic health and putting them at a higher risk for diabetes This study aims to test the hypothesis that by augmenting NP levels using sacubitrilvalsartan among Black Individuals one can improve their metabolic health as measured by insulin sensitivity energy expenditure and help establish the role of NPs in the underlying mechanism behind increased risk for cardiometabolic disease in these population
Detailed Description:
Black individuals are more likely to have a reduced insulin sensitivity which results in a greater risk for diabetes However the reasons for their decreased insulin sensitivity are not clearly understood Natriuretic peptides NPs are hormones produced by the heart that is known to have a wide range of favorable metabolic effects Studies indicate that lower NP levels are associated with a decreased insulin sensitivity and this may be causally related to the development of diabetes
Evidence suggests that Black individuals have low levels of NPs Increased clearance of NPs by neprilysin an NP degrading enzyme contributes to the low levels of NP among Black individuals Since NPs play an important role in the regulation of insulin sensitivity and energy expenditure one can infer that relatively low NP levels are an important biological contributor to the high prevalence rates of cardiometabolic disease in African Americans
Sacubitrilvalsartan is an FDA-approved inhibitor of neprilysin that augment NP levels NP augmentation using sacubitrilvalsartan has been shown to improve insulin sensitivity and lipid metabolism in a small clinical trial among obese White individuals It can be postulated that NP augmentation in populations with relatively low NP levels will help in improving their metabolic health Improvement in the metabolic health following NP augmentation will also help us to outline the relationship between the NP system and the risk of cardiometabolic disease among Black individuals
We hypothesize that NP augmentation among Black individuals will show an improvement in their metabolic health as measured by insulin sensitivity and energy expenditure We hypothesize that African American individuals will show an improvement in their insulin sensitivity and their resting exercise energy expenditure after treatment with sacubitrilvalsartan versus valsartan alone
Our study will have the following aims The first aim is to assess the change in the insulin sensitivity after NP augmentation therapy using sacubitrilvalsartan as compared with NP neutral therapy using valsartan among Black individuals We will measure the change in insulin sensitivity assessed using IVGTT after 12 weeks of intervention We will also assess the change in NP levels a marker of NP augmentation cyclic guanylate monophosphate cGMP levels after intervention and evaluate their relationship with the change in insulin sensitivity
The second aim of our study is to examine the change in the energy expenditure after sacubitrilvalsartan as compared to valsartan alone among Black individuals The individuals enrolled in the first aim will also be examined for the change in resting as well as exercise energy expenditure This will be assessed using standardized protocol performed using the metabolic cart and an exercise treadmill at baseline and after 12 weeks of either sacubitrilvalsartan or valsartan alone
The secondary aim of our study is to assess the GLP-1 response to meals after treatment with sacubitrilvalsartan in Black individuals We will evaluate the change in postprandial GLP-1 response to meals at baseline and after 12 weeks of either sacubitrilvalsartan or valsartan alone
Evidence suggests that Black individuals have low levels of NPs Increased clearance of NPs by neprilysin an NP degrading enzyme contributes to the low levels of NP among Black individuals Since NPs play an important role in the regulation of insulin sensitivity and energy expenditure one can infer that relatively low NP levels are an important biological contributor to the high prevalence rates of cardiometabolic disease in African Americans
Sacubitrilvalsartan is an FDA-approved inhibitor of neprilysin that augment NP levels NP augmentation using sacubitrilvalsartan has been shown to improve insulin sensitivity and lipid metabolism in a small clinical trial among obese White individuals It can be postulated that NP augmentation in populations with relatively low NP levels will help in improving their metabolic health Improvement in the metabolic health following NP augmentation will also help us to outline the relationship between the NP system and the risk of cardiometabolic disease among Black individuals
We hypothesize that NP augmentation among Black individuals will show an improvement in their metabolic health as measured by insulin sensitivity and energy expenditure We hypothesize that African American individuals will show an improvement in their insulin sensitivity and their resting exercise energy expenditure after treatment with sacubitrilvalsartan versus valsartan alone
Our study will have the following aims The first aim is to assess the change in the insulin sensitivity after NP augmentation therapy using sacubitrilvalsartan as compared with NP neutral therapy using valsartan among Black individuals We will measure the change in insulin sensitivity assessed using IVGTT after 12 weeks of intervention We will also assess the change in NP levels a marker of NP augmentation cyclic guanylate monophosphate cGMP levels after intervention and evaluate their relationship with the change in insulin sensitivity
The second aim of our study is to examine the change in the energy expenditure after sacubitrilvalsartan as compared to valsartan alone among Black individuals The individuals enrolled in the first aim will also be examined for the change in resting as well as exercise energy expenditure This will be assessed using standardized protocol performed using the metabolic cart and an exercise treadmill at baseline and after 12 weeks of either sacubitrilvalsartan or valsartan alone
The secondary aim of our study is to assess the GLP-1 response to meals after treatment with sacubitrilvalsartan in Black individuals We will evaluate the change in postprandial GLP-1 response to meals at baseline and after 12 weeks of either sacubitrilvalsartan or valsartan alone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| R01HL163852 | NIH | None | httpsreporternihgovquickSearchR01HL163852 |