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This study has been withdrawn prior to enrollment.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

January 23, 2008
December 10, 2014
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catecholamine levels [ Time Frame: 2 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00608816 on ClinicalTrials.gov Archive Site
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Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Type 1 Diabetes
  • Drug: epinephrine
    Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2
  • Drug: epinephrine
    Epinephrine 0.06 µg/kg/min infusion during two hour experimental period on Day 2
  • Experimental: 1
    Hyperinsulinemic euglycemic glucose clamp study on day 1 Hyperinsulinemic euglycemic clamp study on day 2 with epinephrine infusion
    Intervention: Drug: epinephrine
  • Experimental: 2
    Hyperinsulinemic hypoglycemic glucose clamp x 2 on day 1 Hyperinsulinemic euglycemic clamp with epinephrine infusion on Day 2
    Intervention: Drug: epinephrine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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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
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00608816
IRB #040910-HAAF in T1DM, Q4, Ro1 DK06903-03
No
Steve Davis, Vanderbilt University
Vanderbilt University
Not Provided
Principal Investigator: Stephen N. Davis, MD Vanderbilt University
Vanderbilt University
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP