Racial Differences in the Natriuretic Peptide Response to Glucose Challenge

The University of Alabama at Birmingham

Status: Completed

Conditions: Healthy; Metabolic Syndrome; Natriuretic Peptides

Treatments: Other: Glucose Challenge; Dietary Supplement: Study diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03072602

X16081002

Details and patient eligibility

About

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

Full description

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.

Enrollment: 81 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 2 patient groups

African-American

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Study diet

Other: Glucose Challenge

White

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Study diet

Other: Glucose Challenge