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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

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

Arm Label

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

NCT ID

NCT00607646

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)

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

Arm Type

Experimental

Arm Description

Arm Title

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

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

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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