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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

Page last updated: December 08, 2011

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