Type 2 Diabetes (T2D) Clinical Trials

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The Effects of Natriuretic Peptide Augmentation on Cardiometabolic Health in Black Individuals (NAUTICAL)

Status: Recruiting
Location: See location...
Intervention Type: Drug, Dietary supplement, Other
Study Type: Interventional
Study Phase: Phase 2
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 sacubitril/valsartan, 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Adults: Age more than or equal to 18 years of age

• Self-identified race/ethnicity as African-American or Black

• Blood pressure: 120-160/80-100 mmHg

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Contact Information
Primary
Nehal Vekariya, MS
nvekariya@uabmc.edu
205-934-7173
Time Frame
Start Date: 2020-08-15
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 200
Treatments
Experimental: Sacubitril/Valsartan
We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks of intervention.
Active_comparator: Valsartan
We will enroll 100 adult Black individuals. Each participant will take the assigned dose of medication twice daily for 12 weeks. We evaluate insulin sensitivity and energy expenditure at baseline and after 12 weeks of intervention.
Related Therapeutic Areas
Sponsors
Leads: University of Alabama at Birmingham
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov