Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

NCT00608816 | Withdrawn

• 2 other identifiers: IRB #040910-HAAF in T1DM, Q4Ro1 DK06903-03
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

epinephrine

Outcome Measures

Primary Outcomes (1)

• catecholamine levels

  2 days

Study Arms (2)

1

EXPERIMENTAL

Hyperinsulinemic euglycemic glucose clamp study on day 1 Hyperinsulinemic euglycemic clamp study on day 2 with epinephrine infusion

Drug: epinephrine

2

EXPERIMENTAL

Hyperinsulinemic hypoglycemic glucose clamp x 2 on day 1 Hyperinsulinemic euglycemic clamp with epinephrine infusion on Day 2

Drug: epinephrine

Interventions

epinephrine DRUG

Epinephrine 0.06 µg/kg/min infusion during a two hour experimental period on Day 2

1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C \> 8.5%
• (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C \< 7%
• (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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Epinephrine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Stephen N. Davis, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman of Medicine, University of Maryland, Baltimore

Study Record Dates

• First Submitted: January 23, 2008
• First Posted: February 6, 2008
• Last Updated: December 11, 2014

Record last verified: 2014-12