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Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects

Primary Purpose

Hyperglycemia, Sepsis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dopamine
Sponsored by
Albert Einstein College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperglycemia focused on measuring Dopamine, hyperglycemic clamp, sepsis, hyperglycemia, insulin secretion

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montefiore Medical Center of Albert Einstein College of Medicine

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dopamine

Arm Description

All patients will receive the same intervention.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

counter-regulatory hormones
Counter-regulatory hormone concentrations before, during and after dopamine infusion

Full Information

First Posted
February 3, 2014
Last Updated
August 5, 2016
Sponsor
Albert Einstein College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02053935
Brief Title
Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects
Official Title
Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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. Subjects that meet study criteria will return within 30 days of screening to the clinical research after an overnight fast. One large bore (20 gauge) venous cannula will be inserted in the antecubital fossa for infusion of dopamine and dextrose 20% intravenous solution. Another cannula will be inserted in the contralateral arm for frequent blood sampling. Insulin sensitivity will be determined using the gold standard hyperglycemic clamp as previously described (DeFronzo, 1979).13 Each subject will act as their own control and receive placebo infusion followed by dopamine infusions. Subjects will have their blood pressure, heart rate, and glucose monitored every 10 minutes. 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. C-peptide, insulin, glucagon and catecholamine levels will be drawn at 30 min and 60 min to determine baseline levels prior to dopamine infusion. Then, dopamine (200mg/250ml) will be titrated up to 5 mcg/kg/min with care not to increase blood pressure greater than 160 systolic. C-peptide, insulin level, glucagon, plasma catecholamines will be measured at 90 min and 120 min, 150min, 180min, 210min, 240min. At 120min, 180 min and 240 min glucagon and cortisol levels will also be measured. The total amount of blood withdrawn for entire study will be less than 100 ml. After all blood samples are drawn, dextrose and dopamine infusion will be down-titrated and stopped. The subject will be given lunch and glucose level will be checked. Venous cannulas will then be removed and subject will be sent home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperglycemia, Sepsis
Keywords
Dopamine, hyperglycemic clamp, sepsis, hyperglycemia, insulin secretion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dopamine
Arm Type
Other
Arm Description
All patients will receive the same intervention.
Intervention Type
Drug
Intervention Name(s)
Dopamine
Intervention Description
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.
Primary Outcome Measure Information:
Title
insulin secretion
Description
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
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
counter-regulatory hormones
Description
Counter-regulatory hormone concentrations before, during and after dopamine infusion
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erika Mark, DO
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rubina Heptulla, MD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center of Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

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Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects

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