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Sponsored by: |
Vanderbilt University |
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Information provided by: | Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT00608101 |
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 |
Study Type: | Interventional |
Study Design: | 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: | July 2009 |
Estimated Study Completion Date: | January 2011 |
Estimated Primary Completion Date: | January 2011 (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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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Donna B. Tate | 615-936-1824 | donna.tate@vanderbilt.edu |
Principal Investigator: | Stephen N. Davis, MD | Vanderbilt University |
Responsible Party: | Vanderbilt University ( Stephen N. Davis, MD ) |
Study ID Numbers: | IRB #040907-HAAF in T1DM, Q1, RO1 DK 069803-03 |
Study First Received: | January 23, 2008 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00608101 History of Changes |
Health Authority: | United States: Institutional Review Board |
hypoglycemia exercise corticosteroids |
Anti-Inflammatory Agents Dexamethasone Metabolic Diseases Autoimmune Diseases Antineoplastic Agents, Hormonal Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Diabetes Mellitus Antiemetics Endocrine System Diseases Diabetes Mellitus Type 1 |
Hypoglycemia Hormones Glucocorticoids Diabetes Mellitus, Type 1 Fludrocortisone Peripheral Nervous System Agents Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Dexamethasone acetate |
Dexamethasone Anti-Inflammatory Agents Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hypoglycemia Hormones Therapeutic Uses Fludrocortisone Dexamethasone acetate Autoimmune Diseases Metabolic Diseases |
Immune System Diseases Antineoplastic Agents, Hormonal Diabetes Mellitus Gastrointestinal Agents Endocrine System Diseases Glucocorticoids Pharmacologic Actions Diabetes Mellitus, Type 1 Autonomic Agents Peripheral Nervous System Agents Glucose Metabolism Disorders Central Nervous System Agents |