Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Information provided by (Responsible Party):
Rubina Heptulla, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:
NCT02053935
First received: February 3, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Hyperglycemia
Sepsis
Drug: Dopamine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Dopamine Infusion on Insulin Secretion in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:
  • insulin secretion [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    Counter-regulatory hormone concentrations before, during and after dopamine infusion


Estimated Enrollment: 15
Study Start Date: December 2013
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Dopamine
All patients will receive the same intervention.
Drug: Dopamine
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02053935

Contacts
Contact: Erika Mark, DO 718 741 2065 emarkne@montefiore.org

Locations
United States, New York
Montefiore Medical Center of Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact: Erika Mark, DO    718-741-2065    emarkne@montefiore.org   
Sub-Investigator: Erika Mark, DO         
Principal Investigator: Rubina Heptulla, MD         
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
Investigators
Study Director: Erika Mark, DO Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Rubina Heptulla, MD Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

Responsible Party: Rubina Heptulla, Division Chief of Pediatric Endocrinology, Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier: NCT02053935     History of Changes
Other Study ID Numbers: 2013-286
Study First Received: February 3, 2014
Last Updated: February 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:
Dopamine
hyperglycemic clamp
sepsis
hyperglycemia
insulin secretion

Additional relevant MeSH terms:
Hyperglycemia
Sepsis
Glucose Metabolism Disorders
Metabolic Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Dopamine
Dopamine Agents
Insulin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Hypoglycemic Agents

ClinicalTrials.gov processed this record on August 26, 2014