Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects

NCT02053935 | Completed Phase 1 DMC

• 1 other identifier: 2013-286
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hyperglycemia; Sepsis

Keywords

Dopamine; hyperglycemic clamp; sepsis; hyperglycemia; insulin secretion

Outcome Measures

Primary Outcomes (1)

• insulin secretion

  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

  4 hours

Secondary Outcomes (1)

• counter-regulatory hormones

  4 hours

Study Arms (1)

Dopamine

OTHER

All patients will receive the same intervention.

Drug: Dopamine

Interventions

Dopamine DRUG

Each 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.

Dopamine

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

Study Sites (1)

Montefiore Medical Center of Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Sepsis

Interventions

Dopamine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biogenic Monoamines; Biogenic Amines; Amines; Organic Chemicals; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Erika Mark, DO

  Albert Einstein College of Medicine

  STUDY DIRECTOR

• Rubina Heptulla, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Chief of Pediatric Endocrinology

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 4, 2014
• Study Start: December 1, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (1)