Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3 - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00742521

Purpose

It has been found that in some cases, when a person with Diabetes Mellitus has an episode of low blood sugar,or hypoglycemia, and then later exercises, he or she is vulnerable to another bout of hypoglycemia during that exercise. The purpose of this study is to determine what factors during the previous bout of hypoglycemia might cause another bout of hypoglycemia while exercising later.

Condition	Intervention
Type 1 Diabetes	Procedure: glucose clamp

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Hydrocortisone Cortisol 21-phosphate Cortisol succinate Hydrocortamate Hydrocortisone 21-sodium succinate Hydrocortisone acetate Hydrocortisone cypionate Hydrocortisone hemisuccinate Proctofoam-HC Dextrose

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Active Control, Crossover Assignment
Official Title:	Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Question 3

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

catecholamine measures [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	48
Study Start Date:	December 2001
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Euglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study	Procedure: glucose clamp Day 1 hyperinsulinemic euglycemic glucose clamp procedure x 2 and Day 2 hyperinsulinemic hypoglycemic glucose clamp procedure
2: Active Comparator Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study	Procedure: glucose clamp Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study
3: Active Comparator Euglycemic glucose clamp procedure x 2 with cortisol infusion of 2ug/kg on Day 1 and hypoglycemic glucose clamp procedure on Day 2.	Procedure: glucose clamp Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 2 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.
4: Active Comparator Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 1 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.	Procedure: glucose clamp Hyperinsulinemic euglycemic glucose clamp procedure x 2 with cortisol infusion at 1 ug/kg on Day 1 and hyperinsulinemic hypoglycemic glucose clamp procedure on Day 2.

Detailed Description:

The SPECIFIC AIM of the study outlined in this proposal is to determine if hypoglycemia blunts counterregulatory responses during subsequent exercise in Type 1 Diabetes Mellitus due to physiologic increases in plasma cortisol.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Males and females with Type 1 Diabetes Mellitus will be studied. Subjects recruited will be 18-50 years, with an HBA1c less than 9.5%, who have been diagnosed with diabetes for >5 years, with no clinical evidence of diabetic tissue complications.

Exclusion Criteria:

Subjects with known prior cardiac events will be excluded from the study. Additional exclusion criteria:
1. all medical students (Vanderbilt policy)
2. prior or current history of poor health
3. abnormal results following blood and physical examination
4. pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00742521

Contacts

Contact: Vanessa Briscoe, PhD, NP

615-936-1824

vanessa.j.brisoce@vanderbilt.eedu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Vanessa J Briscoe, PhD, NP 615-936-1824 vanessa.j.briscoe@vanderbilt.edu

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Stephen N Davis, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	IRB#010733, HL056693-10
Study First Received:	August 25, 2008
Last Updated:	December 4, 2008
ClinicalTrials.gov Identifier:	NCT00742521
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

cortisol
catecholamines
Type 1 DM

Study placed in the following topic categories:

Hydrocortisone
Autoimmune Diseases
Metabolic Diseases
Cortisol succinate
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Hydrocortisone acetate
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009