Status:
COMPLETED
Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
18-45 years
Phase:
EARLY_PHASE1
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 specif...
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 supplem...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2018
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00607646
Start Date
October 1 2010
End Date
October 9 2018
Last Update
September 12 2019
Active Locations (1)
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1
University of Maryland, Baltimore
Baltimore, Maryland, United States, 21201