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Completed

NCT Number: NCT03072602

Racial Differences in the Natriuretic Peptide Response to Glucose Challenge

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

Previous studies have shown an association between reduced levels of circulating natriuretic peptides (NPs) and obesity in humans. This association is especially pronounced in those with metabolic syndrome traits and elevated plasma insulin. As previously conducted study has shown that an increase in NPs with weight loss in obese individuals is "primary" and not secondary to alteration in cardiac structure or function.

Previous experimental data suggests that Atrial NP (ANP) has a wide range of favorable metabolic effects including that activation of brown fat and improvement in skeletal muscle oxidative capacity and glucose utilization. New evidence suggests that ANP activation directly modulates insulin sensitivity and energy homeostasis, suggesting that ANP suppression could promote more obesity/insulin resistance. Moreover, ANP exerts potent lipolytic effects in vitro and in vivo. The previous study has shown that a high-carbohydrate challenge in healthy volunteers is associated with a reduction in N-terminal-proANP (NTproANP) but not N-terminal-proB-type NP (NTproBNP) levels. Nonetheless our outcomes were predominantly in Caucasians and warrants replication in other racial groups.

There is no data on the ANP response to high-carbohydrate challenge in African Americans, a racial group with disproportionately greater rates of obesity, insulin resistance, and diabetes as compared to Caucasians. So the investigators have proposed to conduct a pilot study in otherwise healthy, normotensive subjects to examine NP system, especially the effects on MRproANP in response of high-carbohydrate challenge.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Study diet

Dietary Supplement

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

Glucose Challenge

Other

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.

Primary outcomes

  1. Plasma MRproANP

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

    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)

Secondary outcomes

  1. The Difference in Circulating Plasma MRproANP

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

    Change in circulating MRproANP levels in response to glucose challenge between African-Americans and whites (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)

  2. Serum Insulin

    Time frame: At 1 hour after glucose challenge

    The difference in serum insulin levels at 1 hour in response to glucose challenge between African-Americans and whites

  3. Serum Glucose

    Time frame: At 1 hour after glucose challenge

    The difference in serum glucose levels at 1 hour in response to glucose challenge between African-Americans and whites

  4. Plasma NTproBNP

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

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

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

    Time frame: At baseline

    The relative circulating Neprilysin (Membrane Metalloendopeptidase) mRNA quantification (fold change) at baseline between African-Americans and Whites

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

A Study of Racial Differences in Natriuretic Peptides Response to Glucose Challenge

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 7, 2017
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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