Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT00608101|
Recruitment Status : Withdrawn
First Posted : February 6, 2008
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Fludrocortisone Drug: Dexamethasone||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Factorial Assignment|
|Official Title:||Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
U.S. FDA Resources
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
- catecholamines [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00608101
|Principal Investigator:||Stephen N. Davis, MD||Vanderbilt University|