Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- insulin secretion
研究概览
简要总结
This is a clinical study of a drug named dopamine and how it affects our bodies ability to make and secrete insulin. Insulin is a hormone made in the pancreas that helps our body regulate sugar levels. We think that this drug decreases the amount of insulin our body makes and causes our sugar levels to be high. When you are critically ill there can be many adverse effects if you have sugar levels that are too high.
详细描述
Rationale Role of dopamine infusion on pancreatic beta cell function in health and disease remain undetermined in humans. Increasingly, hyperglycemia in the critical care arena bodes poorly on health outcomes.
This study for the first time investigates the role of dopamine infusion in health and has the potential to guide larger studies on impact of dopamine use in critical illness.
Study Design This project will be a prospective, single-center trial to determine the effect of dopamine in healthy subjects using the hyperglycemic clamp.
Study Procedures:
After signing informed consent subjects will undergo screening at the clinical research center after an overnight fast. At this visit, a complete history and physical exam including vital signs, height, weight, BMI, waist circumference will be obtained. Cardiac conditions will be screened using an EKG. Baseline labs will be drawn at this visit, including CBC, chemistry, liver function tests, hemoglobin AIC, thyroid function tests, lipids and cortisol. Females will have a urine beta HCG.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy subjects
- •Age 18-35 years
- •Hemoglobin >12 g/dl
- •Euthyroid or on a stable dose of synthroid
- •Normal EKG, hemoglobin AIC, kidney and liver function
排除标准
- •Prior history of dopamine infusion
- •Past medical history of diabetes, hypertension, myocardial infarction, vaso-occlusive disease or arrhythmias
- •Chronic steroid therapy, oral contraceptive pills, monoamine oxidase inhibitors (MAO-I), anticonvulsants (phenytoin)
- •Pregnant women because dopamine is pregnancy category C
- •Clinical signs of polycystic ovarian syndrome
- •Past medical history of Cushing's disease or pheochromocytoma
- •Sulfa drug allergy
- •Use of any medications or illness determined by the investigators that may affect insulin secretion or insulin sensitivity.
研究组 & 干预措施
Dopamine
All patients will receive the same intervention.
干预措施: Dopamine (Drug)
结局指标
主要结局
insulin secretion
时间窗: 4 hours
Insulin secretion will be assessed via glucose infusion requirement during a hyperglycemic clamp. Insulin and c-peptide levels will be monitored. Insulin secretion will be attenuated by 30% from baseline in subjects receiving dopamine
次要结局
- counter-regulatory hormones(4 hours)
研究者
Rubina Heptulla
Division Chief of Pediatric Endocrinology
Albert Einstein College of Medicine