A Study of Racial Differences in Natriuretic Peptides Response to Glucose Challenge
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Plasma MRproANP
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-40 years
- •Blood pressure less than 140/90
- •Estimated creatinine clearance >60cc/min
- •Willingness to comply with the study diet
排除标准
- •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
结局指标
主要结局
Plasma MRproANP
时间窗: 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)
次要结局
- Serum Insulin(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)
- 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)
- Change in Neprilysin (Membrane Metalloendopeptidase) mRNA Expression Levels Between African-Americans and Whites(At baseline)
- Serum Glucose(At 1 hour after glucose challenge)
研究者
Pankaj Arora, MD
Assistant Professor
University of Alabama at Birmingham