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Hyperglycemia | Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects

Hyperglycemia research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: 1. Healthy subjects 2. Age 18-35 years 3. Hemoglobin >12 g/dl 4. Euthyroid or on a stable dose of synthroid 5. Normal EKG, hemoglobin AIC, kidney and liver function Exclusion Criteria: 1. Prior history of dopamine infusion 2. Past medical history of diabetes, hypertension, myocardial infarction, vaso-occlusive disease or arrhythmias 3. Chronic steroid therapy, oral contraceptive pills, monoamine oxidase inhibitors (MAO-I), anticonvulsants (phenytoin) 4. Pregnant women because dopamine is pregnancy category C 5. Clinical signs of polycystic ovarian syndrome 6. Past medical history of Cushing's disease or pheochromocytoma 7. Sulfa drug allergy 8. Use of any medications or illness determined by the investigators that may affect insulin secretion or insulin sensitivity.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hyperglycemia

Sepsis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DopamineEach subject will receive a priming dose of dextrose 20% to increase their glucose concentration by 125 mg/dl in the first 15 minutes. Then they will receive variable rates of dextrose 20% infusion to maintain glucose level at 180-220 mg/dl. Then, dopamine (200mg/250ml) will be titrated up to 5 mcg/kg/min with care not to increase blood pressure greater than 160 systolic. Dopamine will be infused for 3 hours.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DopamineAll patients will receive the same intervention.

Study Status

Completed

Start Date: December 2013

Completed Date: January 2016

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: insulin secretion

Secondary Outcome: counter-regulatory hormones

Study sponsors, principal investigator, and references

Principal Investigator: Erika Mark, DO

Lead Sponsor: Albert Einstein College of Medicine, Inc.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02053935

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