Mechanisms of Hypoglycemia Associated Autonomic Dysfunction, Q.3

Vanderbilt University

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Procedure: glucose clamp

Study type: Interventional

Funder types: Other

Identifiers

NCT00742521

IRB#010733

HL056693-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

22 participants in 4 patient groups

1

Active Comparator group

Description:

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

Treatment:

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp

2

Active Comparator group

Description:

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

Treatment:

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp

3

Active Comparator group

Description:

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

Treatment:

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp

4

Active Comparator group

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.

Treatment:

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp

Procedure: glucose clamp