Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2
Information source: University of Maryland
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 1 Diabetes
Intervention: Alprazolam (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Maryland Official(s) and/or principal investigator(s):
Stephen N. Davis, MD, Principal Investigator, Affiliation: University of Maryland
Overall contact:
Donna B. Tate, MS, Phone: 410-706-5642, Email: dtate@medicine.umaryland.edu
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.
Clinical Details
Official title: Mechanisms of Hypoglycemia-Associated Autonomic Dysfunction. The Effect of Alprazolam on Exercise Induced Hypoglycemia.
Study design: Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Primary outcome: Change in Epinephrine Levels
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
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
Locations and Contacts
Donna B. Tate, MS, Phone: 410-706-5642, Email: dtate@medicine.umaryland.edu
University of Maryland, Baltimore, Baltimore, Maryland 21201, United States; Recruiting
Donna B. Tate, MS, Phone: 410-706-5642
Stephen N. Davis, MD, Principal Investigator
Additional Information
Starting date: July 2007
Last updated: July 31, 2011
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