Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2
This trial is active, not recruiting.
|Condition||type 1 diabetes|
|Sponsor||University of Maryland|
|Collaborator||National Heart, Lung, and Blood Institute (NHLBI)|
|Start date||July 2007|
|End date||December 2016|
|Trial size||28 participants|
|Trial identifier||NCT00574639, HL056693, HP-00044868|
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.
|Intervention model||factorial assignment|
|Masking||single blind (subject)|
Change in Epinephrine Levels
time frame: 32 weeks
Male or female participants from 18 years up to 50 years old.
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
|Official title||Mechanisms of Hypoglycemia-Associated Autonomic Dysfunction. The Effect of Alprazolam on Exercise Induced Hypoglycemia.|
|Principal investigator||Stephen N. Davis, MD|
|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.|
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