Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Type 1 Diabetes Clinical Trial

Official title:

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3

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
• 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
• 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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Hypoglycemia
• Pure Autonomic Failure
• Type 1 Diabetes

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