Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q5

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

When a patient with Type 1 diabetes exercises, he or she is more prone to low blood sugar, or hypoglycemia. It is known that antecedent exercise can blunt defense responses, called counterregulatory responses to subsequent hypoglycemia in Type 1 DM, causing him or her to be vulnerable to another bout of hypoglycemia. Epinephrine is one of the important hormones in the defense of blood glucose during both exercise and hypoglycemia. We will test the hypothesis that antecedent exercise will blunt the metabolic, neuroendocrine and cardiovascular effects of subsequent epinephrine infusion in Type 1 DM.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Treatments: Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• 28 (14 males, 14 females) conventionally treated Type 1 diabetic patients with HA1C > 8.5%

• 28 (14 males, 14 females) intensively treated Type 1 diabetic patients with HA1C < 7%

• 28 (14 males, 14 females) non-diabetic controls

• Age 18-45 yr.

• Had diabetes for 2-15 years if diabetic subject

• No clinical evidence of diabetic tissue complications, no cardiovascular disease

• Body mass index 21-27kg · m-2

• Normal bedside autonomic function

• Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities

• Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

• Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease

• Hemoglobin of less than 12 g/dl

• Abnormal results following screening tests

• Pregnancy

• Subjects unable to give voluntary informed consent

• Subjects with a recent medical illness

• Subjects with known liver or kidney disease

• Subjects taking steroids

• Subjects taking beta blockers

• Subjects on anticoagulant drugs, anemic, or with known bleeding diseases