Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

NCT ID: NCT00608816

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL

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.

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.

Conditions

Type 1 Diabetes

Keywords

epinephrine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

epinephrine

Intervention Type: DRUG

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

2

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

Group Type: EXPERIMENTAL

epinephrine

Intervention Type: DRUG

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

Interventions

epinephrine

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

Intervention Type: DRUG

epinephrine

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

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Steve Davis

Chairman of Medicine, University of Maryland, Baltimore

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen N. Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Other Identifiers

Ro1 DK06903-03

Identifier Type: -

Identifier Source: secondary_id

IRB #040910-HAAF in T1DM, Q4

Identifier Type: -

Identifier Source: org_study_id