Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

This study is currently recruiting participants.

Verified by Vanderbilt University, June 2009

First Received: December 13, 2007 Last Updated: June 23, 2009 History of Changes

Sponsor:	Vanderbilt University
Collaborator:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00574639

Purpose

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.

Condition	Intervention
Type 1 Diabetes	Drug: Alprazolam

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Factorial Assignment
Official Title:	Autonomic Cardiovascular Regulation - Project 5

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1 Exercise and Physical Fitness Hypoglycemia

Drug Information available for: Alprazolam

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Change in Epinephrine Levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Intervention Details:

1 mg given orally times 2 per study

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

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574639

Contacts

Contact: Donna B. Tate, MS

615-936-1824

donna.tate@vanderbilt.edu

Locations

United States, Tennessee
Vanderbilt University	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Donna B. Tate, MS 615-936-1824 donna.tate@vanderbilt.edu
Principal Investigator: Stephen N. Davis, MD

Sponsors and Collaborators

Vanderbilt University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Stephen N. Davis, MD

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt University ( Stephen N. Davis, MD )
Study ID Numbers:	IRB#070488-Alprazolam-Exercise, HL056693
Study First Received:	December 13, 2007
Last Updated:	June 23, 2009
ClinicalTrials.gov Identifier:	NCT00574639 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

Type 1 Diabetes
Alprazolam
Exercise

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Metabolic Diseases
Autoimmune Diseases
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Diabetes Mellitus
Endocrine System Diseases

Central Nervous System Depressants
Pharmacologic Actions
Alprazolam
Diabetes Mellitus, Type 1
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Glucose Metabolism Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010