Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

Study Overview
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Brief Summary
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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
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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.

Official Title
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Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Question 3

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Procedure: glucose clamp
* Procedure: glucose clamp
* Procedure: glucose clamp
* Procedure: glucose clamp


Participation Criteria
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Eligibility Criteria
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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 pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Euglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study | Procedure: glucose clamp<br>* Day 1 hyperinsulinemic euglycemic glucose clamp procedure x 2 and Day 2 hyperinsulinemic hypoglycemic glucose clamp procedure<br>|
| Active Comparator: 2<br>Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study | Procedure: glucose clamp<br>* Hypoglycemic glucose clamp procedure x 2 on Day 1 and hypoglycemic glucose clamp procedure on Day 2. Control study<br>|
| Active Comparator: 3<br>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<br>* 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.<br>|
| Active Comparator: 4<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| catecholamine measures |  | 8 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cortisol, catecholamines, Type 1 DM