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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

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ClinicalTrials.gov Identifier: NCT00742521
Recruitment Status : Completed
First Posted : August 27, 2008
Last Update Posted : June 10, 2015
Sponsor:
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Procedure: glucose clamp Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Question 3
Study Start Date : March 2001
Actual Primary Completion Date : November 2008
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. catecholamine measures [ Time Frame: 8 months ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Steve Davis, Chairman of Medicine, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00742521     History of Changes
Other Study ID Numbers: IRB#010733
HL056693-10
First Posted: August 27, 2008    Key Record Dates
Last Update Posted: June 10, 2015
Last Verified: June 2015

Keywords provided by Steve Davis, Vanderbilt University:
cortisol
catecholamines
Type 1 DM

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Autonomic Nervous System Diseases
Primary Dysautonomias
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Nervous System Diseases
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Hypoglycemic Agents
Anti-Inflammatory Agents
Physiological Effects of Drugs