Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
Type 1 Diabetes
About this trial
This is an interventional other trial for Type 1 Diabetes focused on measuring hypoglycemia, dehydroepiandrosterone
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
Sites / Locations
- University of Maryland, Baltimore
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
1
2
Arm 3 (optional)
Arm 4
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.