Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Alprazolam (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Vanderbilt University Official(s) and/or principal investigator(s):
Stephen N. Davis, MD, Principal Investigator, Affiliation: Vanderbilt University
Overall contact:
Donna B. Tate, MS, Phone: 615-936-1824, Email: donna.tate@vanderbilt.edu
Summary
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.
Clinical Details
Official title: Autonomic Cardiovascular Regulation - Project 5
Study design: Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment
Primary outcome: Change in Epinephrine Levels
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Donna B. Tate, MS, Phone: 615-936-1824, Email: donna.tate@vanderbilt.edu
Vanderbilt University, Nashville, Tennessee 37232, United States; Recruiting
Donna B. Tate, MS, Phone: 615-936-1824, Email: donna.tate@vanderbilt.edu
Stephen N. Davis, MD, Principal Investigator
Additional Information
Starting date: July 2007
Ending date: December 2009
Last updated: June 23, 2009
|
