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| Sponsored by: |
Vanderbilt University |
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00608101 |
Purpose
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.
| Condition | Intervention |
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Type 1 Diabetes |
Drug: Fludrocortisone Drug: Dexamethasone |
| MedlinePlus related topics: | Diabetes Diabetes Type 1 Hypoglycemia |
| Drug Information available for: | Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Corticosteroids Fludrocortisone Fludrocortisone 21-acetate |
| Study Type: | Interventional |
| Study Design: | Other, Randomized, Single Blind (Subject), Active Control, Factorial Assignment |
| Official Title: | Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1 |
| Estimated Enrollment: | 32 |
| Study Start Date: | October 2008 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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1: Experimental
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.
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Drug: Fludrocortisone
Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
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2: Experimental
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.
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Drug: Dexamethasone
Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1
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Eligibility
| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Donna B. Tate | 615-936-1824 | donna.tate@vanderbilt.edu |
| Vanderbilt University |
| Principal Investigator: | Stephen N. Davis, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University ( Stephen N. Davis, MD ) |
| Study ID Numbers: | IRB #040907-HAAF in T1DM, Q1, RO1 DK 069803-03 |
| First Received: | January 23, 2008 |
| Last Updated: | August 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00608101 |
| Health Authority: | United States: Institutional Review Board |
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