Baltimore, Maryland 21201


Purpose:

Elevations of plasma cortisol, a stress hormone, during prior episodes of low blood sugar (hypoglycemia) appear to be responsible for the deficient responses during subsequent hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone (DHEA), a hormone with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in type 1 diabetic volunteers.


Study summary:

DHEA is the acronym for dehydroepiandrosterone, a steroid hormone produced naturally from cholesterol in the adrenal glands of males and females. It is also sold as an over-the-counter dietary supplement, and seems to have anticorticosteroid effects. DHEA antagonizes the effects of corticosterone on hippocampal function in rats and reduces responses to neural stress in mice. In our lab we have found that administration of the DHEA to rats during antecedent hypoglycemia, preserves counter-regulatory responses to subsequent hypoglycemia. The purpose of this study is to determine if the same response occurs in humans.


Criteria:

Inclusion Criteria: - 28 (14 males, 14 females) Healthy volunteers aged 18-45 yr. - 28 (14 males, 14 females) Type 1 diabetic patients aged 18-45 yr. - HbA1c < 11.0% - Has been diagnosed Type 1 DM - No major diabetic tissue complications (i.e. history of retinopathy, neuropathy, stasis ulcers, etc) - Body mass index < 40kg/m-2 Exclusion Criteria: - pregnancy Medical history- - Hepatic Failure/Jaundice - Renal Failure - Acute Cerebrovascular/ Neurological deficit Physical Exam- - Pneumonia - Fever greater than 38.0 C - Blood labs according to protocol


NCT ID:

NCT00607646


Primary Contact:

Principal Investigator
Stephen N. Davis, MD
University of Maryland

Donna B. Tate
Phone: 410-706-5642
Email: dtate@medicine.umaryland.edu


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21201
United States

Donna Tate
Phone: 410-706-5642
Email: dtate@medicine.umaryland.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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