Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

Type 1 Diabetes Clinical Trial

Official title:

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Question 3

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00742521
• Other study ID #: IRB#010733
• Secondary ID: HL056693-10
• Status: Completed
• Phase: N/A
• First received: August 25, 2008
• Last updated: June 9, 2015
• Start date: March 2001
• Est. completion date: June 2009

Study information

• Verified date: June 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Hypoglycemia
• Primary Dysautonomias
• Type 1 Diabetes

Intervention

Procedure:
• glucose clamp
Day 1 hyperinsulinemic euglycemic glucose clamp procedure x 2 and Day 2 hyperinsulinemic hypoglycemic glucose clamp procedure
• glucose clamp
Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study
• 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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	catecholamine measures		8 months	No