Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.

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

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Alprazolam

Criteria

Inclusion Criteria:

• 16 (8 males, 8 females) Type 1 diabetes patients aged 18-45 yr.

• 16 (8 males, 8 females) healthy controls aged 18-45 yr.

• HbA1c > 7.0% (Type 1 diabetes patients)

• Had diabetes for 2-15 years (Type 1 diabetes patients)

• No clinical evidence of diabetic tissue complications (Type 1 diabetes patients)

• Body mass index 21-30 kg · 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 known liver or kidney disease

• Subjects taking steroids

• Subjects taking beta blockers

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