Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2009-06-30

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.

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Participants

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

glucose clamp

Intervention Type PROCEDURE

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

2

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

Group Type ACTIVE_COMPARATOR

glucose clamp

Intervention Type PROCEDURE

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

3

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

Group Type ACTIVE_COMPARATOR

glucose clamp

Intervention Type PROCEDURE

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.

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.

Group Type ACTIVE_COMPARATOR

glucose clamp

Intervention Type PROCEDURE

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.

Interventions

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glucose clamp

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

Intervention Type PROCEDURE

glucose clamp

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

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

1. all medical students (Vanderbilt policy)
2. prior or current history of poor health
3. abnormal results following blood and physical examination
4. pregnancy

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No