Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

Early Phase 1CompletedNCT00574639

University of Maryland, Baltimore14 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes

Interventions

AlprazolamDRUG

1 mg given orally prior to morning and afternoon clamps on Day 1

PlaceboDRUG

1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion * 14 Type 1 DM patients (7 male and 7 female) aged 18-50 years * HBA1c \> 6% * BMI\<35 kg/m2 * 14 healthy individuals (7 male and 7 female) aged 18-50 years, BMI matched Exclusion * Pregnant women * Subjects unable to give voluntary informed consent * Subjects on anticoagulant drugs, anemic or with known bleeding diatheses * Subjects taking any of the following medications will be excluded: Non-selective Beta Blockers, Sedative-Hypnotics, Anticonvulsants, Antiparkinsonian drugs, Antipsychotics, Antidepressants, Mood stabilizers, CNS Stimulants, Opioids, Hallucinogens * Subjects with a recent medical illness * Subjects with a history of hypertension, heart disease, cerebrovascular incidents * Subjects with known liver or kidney disease Physical Exam Exclusion Criteria * History of uncontrolled severe hypertension (i.e., blood pressure greater than 150/95) * Clinically significant Cardiac Abnormalities (e.g. Heart Failure, Arrhythmia) * Pneumonia * Hepatic Failure /Jaundice * Renal Failure * Acute Cerebrovascular/ Neurological deficit * Fever greater than 38.0 C Screening Laboratory blood tests Exclusion Criteria according to protocol

Locations (1)

University of Maryland, Baltimore

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Change in Epinephrine Levels

Time frame: 32 weeks

Data from ClinicalTrials.gov

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