Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Question 3

Sponsors

Lead Sponsor: Vanderbilt University

Source 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.

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.

Overall Status Completed
Start Date March 2001
Completion Date June 2009
Primary Completion Date November 2008
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
catecholamine measures 8 months
Enrollment 22
Condition
Intervention

Intervention Type: Procedure

Intervention Name: glucose clamp

Description: Day 1 hyperinsulinemic euglycemic glucose clamp procedure x 2 and Day 2 hyperinsulinemic hypoglycemic glucose clamp procedure

Arm Group Label: 1

Intervention Type: Procedure

Intervention Name: glucose clamp

Description: Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study

Arm Group Label: 2

Intervention Type: Procedure

Intervention Name: glucose clamp

Description: 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.

Arm Group Label: 3

Intervention Type: Procedure

Intervention Name: glucose clamp

Description: 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.

Arm Group Label: 4

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Stephen N Davis, MD Principal Investigator Vanderbilt University
Location
Facility: Vanderbilt University
Location Countries

United States

Verification Date

June 2015

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Vanderbilt University

Investigator Full Name: Steve Davis

Investigator Title: Chairman of Medicine

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 1

Type: Active Comparator

Description: Euglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study

Label: 2

Type: Active Comparator

Description: Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study

Label: 3

Type: Active Comparator

Description: Euglycemic glucose clamp procedure x 2 with cortisol infusion of 2ug/kg on Day 1 and hypoglycemic glucose clamp procedure on Day 2.

Label: 4

Type: Active Comparator

Description: 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.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Masking: Single (Participant)

Source: ClinicalTrials.gov