View Clinical Trial (Medical Research Study)
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3
| City: |
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Baltimore |
| State: |
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Maryland |
| Zip Code: |
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21201 |
| Conditions: |
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Type 1 Diabetes |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00607646 |
| Primary Contact: |
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Principal Investigator
Stephen N. Davis, MD
University of Maryland, Baltimore County
Donna B. Tate
Phone: 410-706-5642
Email: dtate@medicine.umaryland.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Baltimore, Maryland 21201
United States
Donna Tate
Phone: 410-706-5642
Email: dtate@medicine.umaryland.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 18, 2013 |
| Modifications to this listing: |
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