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Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dehydroepiandrosterone
Placebo
Sponsored by
University of Maryland, Baltimore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes focused on measuring hypoglycemia, dehydroepiandrosterone

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Maryland, Baltimore

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

Arm 3 (optional)

Arm 4

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Change in level of catecholamines in blood from baseline

Secondary Outcome Measures

Full Information

First Posted
January 16, 2008
Last Updated
September 10, 2019
Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00607646
Brief Title
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
Official Title
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 3
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 9, 2018 (Actual)
Study Completion Date
October 9, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Maryland, Baltimore
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
hypoglycemia, dehydroepiandrosterone

7. Study Design

Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 3 (optional)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm 4
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Dehydroepiandrosterone
Other Intervention Name(s)
DHEA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral administration prior to each clamp period x2 on day 1. Hyperinsulinemic hypoglycemia on day 2.
Primary Outcome Measure Information:
Title
Change in level of catecholamines in blood from baseline
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen N. Davis, MD
Organizational Affiliation
University of Maryland, Baltimore
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Maryland, Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States

12. IPD Sharing Statement

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Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

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