Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

This study has been completed.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00742521
First received: August 25, 2008
Last updated: October 12, 2010
Last verified: October 2010
  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

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

Resource links provided by NLM:


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: March 2001
Study Completion Date: June 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
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
Active Comparator: 2
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
Active Comparator: 3
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.
Active Comparator: 4
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

Locations
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232
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: NCT00742521     History of Changes
Other Study ID Numbers: IRB#010733, HL056693-10
Study First Received: August 25, 2008
Last Updated: October 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
cortisol
catecholamines
Type 1 DM

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hydrocortisone
Hypoglycemic Agents
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 16, 2014