Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q4

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 4

Sponsors

Lead Sponsor: Vanderbilt University

Source Vanderbilt University
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.

Overall Status Withdrawn
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
catecholamine levels 2 days
Condition
Intervention

Intervention Type: Drug

Intervention Name: epinephrine

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

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: epinephrine

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

Arm Group Label: 2

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Stephen N. Davis, MD Principal Investigator Vanderbilt University
Verification Date

December 2014

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Vanderbilt University

Investigator Full Name: Steve Davis

Investigator Title: Chairman of Medicine, University of Maryland, Baltimore

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

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

Label: 2

Type: Experimental

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

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: Single (Participant)

Source: ClinicalTrials.gov