Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Question 3
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Vanderbilt University
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- catecholamine measures
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •all medical students (Vanderbilt policy)
- •prior or current history of poor health
- •abnormal results following blood and physical examination
Arms & Interventions
1
Euglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study
Intervention: glucose clamp (Procedure)
2
Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study
Intervention: glucose clamp (Procedure)
3
Euglycemic glucose clamp procedure x 2 with cortisol infusion of 2ug/kg on Day 1 and hypoglycemic glucose clamp procedure on Day 2.
Intervention: glucose clamp (Procedure)
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.
Intervention: glucose clamp (Procedure)
Outcomes
Primary Outcomes
catecholamine measures
Time Frame: 8 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Steve Davis
Chairman of Medicine
Vanderbilt University