Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single Blind (Subject)
|Official Title:||Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1|
- catecholamines [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Estimated Study Completion Date:||January 2011|
|Estimated Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Day 1 hyperinsulinemic euglycemic clamps with either 0.2 mg fludrocortisone, 0.75 mg Dexamethasone, or both given orally before each morning and afternoon clamp. Day 2 hyperinsulinemic hypoglycemic glucose clamp.
Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
Fludrocortisone will be administered in doses of 0.05mg, 0.1mg and 0.2 mg form at the start of each clamp period on day 1. Dexamethasone will be administered orally in the doses of 0.18 mg, 0.375mg and 0.75mg doses. The combination of the 0.05mg fludrocortisone and 0.18mg dexamethasone and 0.1mg of fludrocortisone and 0.375 mg doses will be administered at the start of each day 1 clamp period. Day 2 90 minutes of moderate exercise.
Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1
Please refer to this study by its ClinicalTrials.gov identifier: NCT00608101
|Contact: Donna B. Tatefirstname.lastname@example.org|
|Principal Investigator:||Stephen N. Davis, MD||Vanderbilt University|