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| Sponsored by: |
Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00607646 |
Purpose
Elevations of plasma cortisol during the prior episodes of low blood sugar appear to be responsible for the deficient responses during subsequent hypoglycemia. Our specific aim is to determine if dehydroepiandrosterone, a hormone with anti-corticosteroid actions, can prevent hypoglycemia associated autonomic failure in type 1 diabetic volunteers.
| Condition | Intervention |
|---|---|
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Type 1 Diabetes |
Drug: Dehydroepiandrosterone Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Randomized, Single Blind (Subject), Placebo Control, Factorial Assignment |
| Official Title: | Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3 |
| Estimated Enrollment: | 16 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Hyperinsulinemic Euglycemic and hypoglycemic clamp studies with oral administration of DHEA prior to each clamp x2 on day 1. Day 2 hyperinsulinemic hypoglycemia.
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Drug: Dehydroepiandrosterone
A placebo tablet or a tablet containing 400 mg of DHEA will be given orally before each hyperinsulinemic euglycemic clamps on day 1. Day 2 hyperinsulinemic hypoglycemia.
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2: Experimental
Day 1 hyperinsulinemic euglycemia and hypoglycemia with placebo dose given prior to each clamp. Day 2 hypoglycemia.
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Drug: Placebo
Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Donna B. Tate | 615-936-1824 | donna.tate@vanderbilt.edu |
| Principal Investigator: | Stephen N. Davis, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University ( Stephen N. Davis, MD ) |
| Study ID Numbers: | IRB #040909-HAAF in T1DM, Q3, RO1 DK069803-03 |
| Study First Received: | January 16, 2008 |
| Last Updated: | July 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00607646 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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hypoglycemia dexamethasone |
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Dexamethasone DHEA (Dehydroepiandrosterone) Metabolic Diseases Autoimmune Diseases Immunologic Factors Adjuvants, Immunologic Diabetes Mellitus Endocrine System Diseases |
Dehydroepiandrosterone Diabetes Mellitus Type 1 Hypoglycemia Diabetes Mellitus, Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Dexamethasone acetate |
|
Metabolic Diseases Autoimmune Diseases Immune System Diseases Immunologic Factors Physiological Effects of Drugs Diabetes Mellitus Adjuvants, Immunologic |
Endocrine System Diseases Dehydroepiandrosterone Hypoglycemia Pharmacologic Actions Diabetes Mellitus, Type 1 Glucose Metabolism Disorders |
