Type 1 Diabetes
Conditions
Keywords
hypoglycemia, dehydroepiandrosterone
Brief 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.
Detailed 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.
Interventions
DRUGDehydroepiandrosterone
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.
DRUGPlacebo
Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in level of catecholamines in blood from baseline | 6 weeks |
Countries
United States
Outcome results
None listed