Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00607646 |
Recruitment Status :
Completed
First Posted : February 6, 2008
Last Update Posted : September 12, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Type 1 Diabetes | Drug: Dehydroepiandrosterone Drug: Placebo | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | October 2010 |
Actual Primary Completion Date : | October 9, 2018 |
Actual Study Completion Date : | October 9, 2018 |

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 Name: 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 Name: 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. |
- Change in level of catecholamines in blood from baseline [ Time Frame: 6 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607646
United States, Maryland | |
University of Maryland, Baltimore | |
Baltimore, Maryland, United States, 21201 |
Principal Investigator: | Stephen N. Davis, MD | University of Maryland, Baltimore |
Responsible Party: | Stephen N. Davis, MBBS, Professor, University of Maryland, Baltimore |
ClinicalTrials.gov Identifier: | NCT00607646 |
Other Study ID Numbers: |
HP-00044672-DHEA R01DK069803-03 ( U.S. NIH Grant/Contract ) |
First Posted: | February 6, 2008 Key Record Dates |
Last Update Posted: | September 12, 2019 |
Last Verified: | September 2019 |
hypoglycemia dehydroepiandrosterone |
Pure Autonomic Failure Diabetes Mellitus, Type 1 Hypoglycemia Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Dehydroepiandrosterone Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |