Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

• Status: Completed
• Trial end date: 2018-10-09
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Dehydroepiandrosterone; Hypoglycemic Agents

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