An Early Phase 1 interventional study of Dehydroepiandrosterone and Placebo in Type 1 Diabetes, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by University of Maryland, Baltimore · Early Phase 1, Interventional, and Other
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.
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.
56 studies on the registry are indexed under Pure Autonomic Failure; 11 are open to participants now.
This study's enrollment of 50 is above the median of 44 across 41 interventional studies indexed under Pure Autonomic Failure.
Browse Pure Autonomic Failure studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Hyperinsulinemic (high dose insulin) hypoglycemic clamp studies with oral administration of DHEA or placebo prior to each clamp x 2 on day 1. Day 2 hyperinsulinemic hypoglycemia. Participant randomized to either DHEA or placebo for baseline trial (arm 1) and 6 weeks treatment.
Drug: Dehydroepiandrosterone
Following 6 weeks randomized treatment, Day 1 hyperinsulinemic hypoglycemic clamps x 2 with DHEA or placebo dose given prior to each clamp. Day 2 hypoglycemia with prior dose of randomized treatment.
Drug: Dehydroepiandrosterone
Individuals will be asked to return after at least 2 months and repeat the trial they did not complete (for example, placebo if they were in the DHEA trial before). Again Day 1 would consist of two hyperinsulinemic clamps with placebo or DHEA given orally. Day 2 hyperinsulinemic hypoglycemic clamp with oral administration of placebo or DHEA.
Drug: Placebo
Following 6 weeks randomized treatment, Day 1 hyperinsulinemic hypoglycemic clamps x 2 with DHEA or placebo dose given prior to each clamp. Day 2 hypoglycemia with prior dose of randomized treatment.
Drug: Placebo
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.
Also known as: DHEA
Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
Change in level of catecholamines in blood from baseline
Time frame: 6 weeks
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore