Official Title: “Autonomic Cardiovascular Regulation - Project 5”

The purpose of this study is to determine the way by which Alprazolam (Xanax) an anti-anxiety drug affects specialized molecules in your brain called GABA (A) receptors that alter your body's ability to defend itself from low blood sugar (hypoglycemia). We hypothesize that prior activation of GABA (A) receptors may result in blunting of counterregulatory responses during subsequent hypoglycemia and exercise.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment

Study Primary Completion Date: July 2009

The ultimate goal of this project is to identify treatments and approaches that will allow patients with diabetes to enjoy all the benefits of good glycemic control without the damaging limitations of severe hypoglycemia. The specific aim of this study is to determine if gamma aminobutyric acid (GABA A) receptors plays a role in the development of exercise associated autonomic dysfunction in type 1 diabetes and healthy man.

Intervention(s) in this Clinical Trial

• Drug: Alprazolam
  • 1 mg given orally times 2 per study

Primary Measures

• Change in Epinephrine Levels
  • Time Frame: 2 years
    Safety Issue?: No

Inclusion Criteria:

• 14 Type 1 DM patients (7 male and 7 female) aged 18-50 years
• HBA1c > 6.0%
• BMI<35 kg/m2
• 14 healthy individuals (7 male and 7 female) aged 18-50 years, BMI matched

Exclusion Criteria:

• Pregnant women
• Subjects unable to give voluntary informed consent
• Subjects on anticoagulant drugs, anemic or with known bleeding diatheses
• Subjects with a recent medical illness
• Subjects with a history of hypertension, heart disease, cerebrovascular incidents
• Subjects with known liver or kidney disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Stephen N. Davis, MD Principal Investigator Vanderbilt University  

Overall Contact: Donna B. Tate, MS 615-936-1824 donna.tate@vanderbilt.edu

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00574639

Study ID Number: IRB#070488-Alprazolam-Exercise

ClinicalTrials.gov Identifier: NCT00574639

Health Authority: United States: Institutional Review Board