Hypoglycemia Associated Autonomic Failure in Type 1 Diabetes Mellitus

The recruitment status of this study is unknown because the information has not been verified recently.

Verified July 2009 by Vanderbilt University.
Recruitment status was Not yet recruiting

Sponsor:

Information provided by:

Vanderbilt University

ClinicalTrials.gov Identifier:

NCT00608101

First received: January 23, 2008

Last updated: July 17, 2009

Last verified: July 2009

History of Changes

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (Subject)
Official Title:	Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 1

Resource links provided by NLM:

Genetics Home Reference related topics: type 1 diabetes

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia Steroids

Drug Information available for: Dexamethasone Fludrocortisone acetate Dexamethasone acetate Dexamethasone sodium phosphate

U.S. FDA Resources

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:	September 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 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
Experimental: 2 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

Experimental: 1

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

Experimental: 2

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:	Stephen N. Davis, MD, Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00608101 History of Changes
Other Study ID Numbers:	IRB #040907-HAAF in T1DM, Q1, RO1 DK 069803-03
Study First Received:	January 23, 2008
Last Updated:	July 17, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

hypoglycemia
exercise
corticosteroids

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Pure Autonomic Failure
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Fludrocortisone

Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 23, 2013

To Top