Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Alprazolam

Criteria

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