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OpenTrials
Completed

NCT Number: NCT00607646

Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

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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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dehydroepiandrosterone

Drug

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.

Other names: DHEA

Placebo

Drug

Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.

Primary outcomes

  1. Change in level of catecholamines in blood from baseline

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University of Maryland, Baltimore

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3

Important dates

Study start
2010
Primary completion
2018
Study completion
2018
First posted
Feb 6, 2008
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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