Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus - Full Text View

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
Type 1 Diabetes	Drug: Fludrocortisone Drug: Dexamethasone

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Dexamethasone Dexamethasone acetate Doxiproct plus Fludrocortisone Fludrocortisone 21-acetate Dexamethasone Sodium Phosphate

U.S. FDA Resources

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

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

catecholamines [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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
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.	Drug: Fludrocortisone Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1
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.	Drug: Dexamethasone Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1

Arms

Assigned Interventions

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.

Drug: Fludrocortisone

Oral Fludrocortisone 0.2 mg x 2 prior to each experimental period on Day 1

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.

Drug: Dexamethasone

Oral Dexamethasone 0.75 mg x 2 administered prior to each experimental period on Day 1

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00608101

Contacts

Contact: Donna B. Tate

615-936-1824

donna.tate@vanderbilt.edu

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Stephen N. Davis, MD

Vanderbilt University

More Information

No publications provided

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

Keywords provided by Vanderbilt University:

hypoglycemia
exercise
corticosteroids

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 07, 2009