Clinical trial NCT00574639: Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2
Official title: Mechanisms of Hypoglycemia-Associated Autonomic Dysfunction. The Effect of Alprazolam on Exercise Induced Hypoglycemia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Alprazolam
Exercise
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2007-12-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Change in Epinephrine Levels
timeFrame: 32 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Stephen N. Davis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hedrington MS, Tate DB, Younk LM, Davis SN. Effects of Antecedent GABA A Receptor Activation on Counterregulatory Responses to Exercise in Healthy Man. Diabetes. 2015 Sep;64(9):3253-61. doi: 10.2337/db15-0212. Epub 2015 Apr 21.