Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT00607646

Run by

University of Maryland, Baltimore

People needed

50

Starts

2010-10-01

Expected to finish

2018-10-09

Last updated by the study team

2019-09-12

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Maryland, Baltimore — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.