Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4 - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00608816

Purpose

Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Condition	Intervention
Type 1 Diabetes	Drug: epinephrine

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Epinephrine Epinephrine bitartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Active Control, Crossover Assignment
Official Title:	Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

catecholamine levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	July 2009
Estimated Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Hyperinsulinemic euglycemic glucose clamp study on day 1 Hyperinsulinemic euglycemic clamp study on day 2 with epinephrine infusion	Drug: epinephrine Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2
2: Experimental Hyperinsulinemic hypoglycemic glucose clamp x 2 on day 1 Hyperinsulinemic euglycemic clamp with epinephrine infusion on Day 2	Drug: epinephrine Epinephrine 0.06 µg/kg/min infusion during two hour experimental period on Day 2

Detailed Description:

When a person had previously experienced bouts of low blood sugar, or hypoglycemia, his or her counterregulatory responses to hypoglycemia would be weakened. This is especially true and important for a person with Type 1 diabetes, because it will cause him or her to be vulnerable to another bout of hypoglycemia, and cause hypoglycemia unawareness, which can lead to serious or even life-threatening consequences. Epinephrine is one of the important hormones in the defense of hypoglycemia. We will test the hypothesis that antecedent hypoglycemia will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C > 8.5%
28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C < 7%
28 (14 males, 14 females) non-diabetic controls
Age 18-45 yr.
Had diabetes for 2-15 years if diabetic subject
No clinical evidence of diabetic tissue complications, no cardiovascular disease
Body mass index 21-27kg · m-2
Normal bedside autonomic function
Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
Hemoglobin of less than 12 g/dl
Abnormal results following screening tests
Pregnancy
Subjects unable to give voluntary informed consent
Subjects with a recent medical illness
Subjects with known liver or kidney disease
Subjects taking steroids
Subjects taking beta blockers
Subjects on anticoagulant drugs, anemic, or with known bleeding diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608816

Contacts

Contact: Donna Tate

615-936-1824

donna.tate@vanderbilt.edu

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Stephen N. Davis, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	IRB #040910-HAAF in T1DM, Q4, Ro1 DK06903-03
Study First Received:	January 23, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00608816
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

epinephrine

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Epinephrine
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Anti-Asthmatic Agents

Cardiovascular Agents
Pharmacologic Actions
Adrenergic Agonists
Mydriatics
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Peripheral Nervous System Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 16, 2009