Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Procedure: glucose clamp

• Registration Number: NCT00742521
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2001-03
• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-26
• Study First Posted: 2008-08-27
• Primary Completion: 2008-11
• Study Completion: 2009-06
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-09
• Last Update Posted: 2015-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	glucose clamp	Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study
4	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.
1	glucose clamp	Euglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study
3	glucose clamp	Euglycemic glucose clamp procedure x 2 with cortisol infusion of 2ug/kg on Day 1 and hypoglycemic glucose clamp procedure on Day 2.

Primary Outcome Measures

Name	Time	Method
catecholamine measures	8 months

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States