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Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT00607646
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
50
Enrollment
1
Location
4
Arms
96.3
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Early Phase 1

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Oct 9, 2018
Actual Study Completion Date :
Oct 9, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

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
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

    		•
    Experimental: 2

    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
    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

    		•
    Experimental: Arm 3 (optional)

    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
    Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
    Experimental: Arm 4

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

    Outcome Measures

    Primary Outcome Measures

    1. Change in level of catecholamines in blood from baseline [6 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Maryland, Baltimore Baltimore Maryland United States 21201

    Sponsors and Collaborators

    • University of Maryland, Baltimore
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    Investigators

    • Principal Investigator: Stephen N. Davis, MD, University of Maryland, Baltimore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Stephen N. Davis, MBBS, Professor, University of Maryland, Baltimore
    ClinicalTrials.gov Identifier:
    NCT00607646
    Other Study ID Numbers:
    • HP-00044672-DHEA
    • R01DK069803-03
    First Posted:
    Feb 6, 2008
    Last Update Posted:
    Sep 12, 2019
    Last Verified:
    Sep 1, 2019
    Keywords provided by Stephen N. Davis, MBBS, Professor, University of Maryland, Baltimore
    hypoglycemia
    dehydroepiandrosterone
    Additional relevant MeSH terms:
    Pure Autonomic Failure
    Diabetes Mellitus, Type 1
    Hypoglycemia
    Dehydroepiandrosterone

    Study Results

    No Results Posted as of Sep 12, 2019