NCT03072602

Brief Summary

The purpose of the study is to discover any racial dissimilarity in the response of Natriuretic peptide (NP) system to acute metabolic influences such as a high carbohydrate challenge

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
3 years until next milestone

Results Posted

Study results publicly available

September 23, 2021

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.6 years

First QC Date

February 27, 2017

Results QC Date

May 28, 2021

Last Update Submit

June 15, 2023

Conditions

HealthyNatriuretic PeptidesMetabolic Syndrome

Keywords

Racial differences

Outcome Measures

Primary Outcomes (1)

  • Plasma MRproANP

    Change in circulating MRproANP levels in response to glucose challenge in African-Americans (Linear mixed models using MRproANP as the dependent variable and time as the independent variable were used. Values are predicted log MRproANP with 95% CI)

    From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days

Secondary Outcomes (5)

  • The Difference in Circulating Plasma MRproANP

    From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days

  • Serum Insulin

    At 1 hour after glucose challenge

  • Serum Glucose

    At 1 hour after glucose challenge

  • Plasma NTproBNP

    From 1st hour to 10th hour on the main study visit day after consuming study meals for 3 days

  • Change in Neprilysin (Membrane Metalloendopeptidase) mRNA Expression Levels Between African-Americans and Whites

    At baseline

Study Arms (2)

African-American

EXPERIMENTAL

Healthy self-identified African-American participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.

Dietary Supplement: Study dietOther: Glucose Challenge

White

ACTIVE COMPARATOR

Healthy self-identified white participants will be enrolled and each will undergo a physical exam and screening tests to determine participants' eligibility. Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB). On 4th day, participants will come to the clinic in fasting state and drink 75 gm of oral glucose solution, followed by blood collection every hour for 8 hours.

Dietary Supplement: Study dietOther: Glucose Challenge

Interventions

Study dietDIETARY_SUPPLEMENT

Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).

African-AmericanWhite
Glucose ChallengeOTHER

Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.

African-AmericanWhite

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years
  • Blood pressure less than 140/90
  • Estimated creatinine clearance \>60cc/min
  • Willingness to comply with the study diet

You may not qualify if:

  • History of hypertension
  • History of cardiovascular, renal, or liver disease
  • Diabetes or use of glucose-lowering medications
  • Use of vasoactive or diuretic medications
  • Atrial fibrillation
  • Anemia (Hematocrit \< 41% in men and \<35% in women
  • Abnormal serum sodium or potassium
  • Urine β-HCG consistent with pregnancy
  • Abnormal liver function tests (\>3x upper limit of normal)
  • Women taking hormonal birth control
  • Current smokers
  • Regular users of non-steroid anti-inflammatory medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (4)

  • Arora P, Wu C, Hamid T, Arora G, Agha O, Allen K, Tainsh RET, Hu D, Ryan RA, Domian IJ, Buys ES, Bloch DB, Prabhu SD, Bloch KD, Newton-Cheh C, Wang TJ. Acute Metabolic Influences on the Natriuretic Peptide System in Humans. J Am Coll Cardiol. 2016 Feb 23;67(7):804-812. doi: 10.1016/j.jacc.2015.11.049.

    PMID: 26892417BACKGROUND

  • Arora P, Reingold J, Baggish A, Guanaga DP, Wu C, Ghorbani A, Song Y, Chen-Tournaux A, Khan AM, Tainsh LT, Buys ES, Williams JS, Heublein DM, Burnett JC, Semigran MJ, Bloch KD, Scherrer-Crosbie M, Newton-Cheh C, Kaplan LM, Wang TJ. Weight loss, saline loading, and the natriuretic peptide system. J Am Heart Assoc. 2015 Jan 16;4(1):e001265. doi: 10.1161/JAHA.114.001265.

    PMID: 25595796BACKGROUND

  • Wu C, Arora P, Agha O, Hurst LA, Allen K, Nathan DI, Hu D, Jiramongkolchai P, Smith JG, Melander O, Trenson S, Janssens SP, Domian I, Wang TJ, Bloch KD, Buys ES, Bloch DB, Newton-Cheh C. Novel MicroRNA Regulators of Atrial Natriuretic Peptide Production. Mol Cell Biol. 2016 Jun 29;36(14):1977-87. doi: 10.1128/MCB.01114-15. Print 2016 Jul 15.

    PMID: 27185878BACKGROUND

  • Patel N, Russell GK, Musunuru K, Gutierrez OM, Halade G, Kain V, Lv W, Prabhu SD, Margulies KB, Cappola TP, Arora G, Wang TJ, Arora P. Race, Natriuretic Peptides, and High-Carbohydrate Challenge: A Clinical Trial. Circ Res. 2019 Nov 8;125(11):957-968. doi: 10.1161/CIRCRESAHA.119.315026. Epub 2019 Oct 6.

    PMID: 31588864RESULT

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Pankaj Arora
Organization
UNIVERSITY OF ALABAMA AT BIRMINGHAM
parora@uabmc.edu
12059754720

Study Officials

  • Pankaj Arora, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Each participant will be enrolled into one of the two groups by race.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 27, 2017

First Posted

March 7, 2017

Study Start

March 1, 2017

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

June 22, 2023

Results First Posted

September 23, 2021

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)