Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00608816
First received: January 23, 2008
Last updated: December 10, 2014
Last verified: December 2014
  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

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

Resource links provided by NLM:


Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • catecholamine levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Enrollment: 0
Arms Assigned Interventions
Experimental: 1
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
Experimental: 2
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00608816

Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Steve Davis, Chairman of Medicine, University of Maryland, Baltimore, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00608816     History of Changes
Other Study ID Numbers: IRB #040910-HAAF in T1DM, Q4, Ro1 DK06903-03
Study First Received: January 23, 2008
Last Updated: December 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
epinephrine

Additional relevant MeSH terms:
Epinephrine
Epinephryl borate
Racepinephrine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Mydriatics
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses
Vasoconstrictor Agents

ClinicalTrials.gov processed this record on March 25, 2015