Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

• Status: Withdrawn
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine what corticosteroid receptor (and the dose of) is responsible for cortisol inducing hypoglycemia associated autonomic dysfunction in Type 1 DM. Specifically, we aim to determine whether stimulating the type 1 corticosteroid receptor (via fludrocortisone), the type 2 corticosteroid receptor (via dexamethasone), or both causes hypoglycemia associated autonomic dysfunction in Type 1 DM.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fludrocortisone

Criteria

Inclusion Criteria:

• 16 (8 males, 8 females) Type 1 diabetic patients aged 18-45 yr.

• HbA1c > 7.0%

• Had diabetes for 2-15 years

• No clinical evidence of diabetic tissue complications

• 16 (8 males, 8 females) Healthy volunteers aged 18-45 yrs.

• Body mass index < 27kg · m-2

Exclusion Criteria:

• Prior or current history of poor health

• Abnormal results following blood and physical examination

• Pregnancy