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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00607646
Other study ID # HP-00044672-DHEA
Secondary ID R01DK069803-03
Status Completed
Phase Early Phase 1
First received
Last updated
Start date October 2010
Est. completion date October 9, 2018

Study information

Verified date September 2019
Source University of Maryland, Baltimore
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 9, 2018
Est. primary completion date October 9, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
Dehydroepiandrosterone
Placebo tablets or tablets containing DHEA will be given orally before each hyperinsulinemic clamps on day 1 (x 2). Placebo tablets or tablets containing DHEA will be given orally before Day 2 hyperinsulinemic hypoglycemic clamp x 1.
Placebo
Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.

Locations

Country Name City State
United States University of Maryland, Baltimore Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
University of Maryland, Baltimore National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in level of catecholamines in blood from baseline 6 weeks
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