Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

Type 1 Diabetes Clinical Trial

— Alp Ex  

Official title:

Mechanisms of Hypoglycemia-Associated Autonomic Dysfunction. The Effect of Alprazolam on Exercise Induced Hypoglycemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00574639
• Other study ID #: HP-00044868
• Secondary ID: HL056693
• Status: Completed
• Phase: Early Phase 1
• Start date: July 2007
• Est. completion date: June 2016

Study information

• Verified date: September 2019
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Autonomic Nervous System Diseases
• Diabetes Mellitus, Type 1
• Hypoglycemia
• Primary Dysautonomias
• Type 1 Diabetes

Intervention

Drug:
• Alprazolam
1 mg given orally prior to morning and afternoon clamps on Day 1
• Placebo
1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)

Locations

Country	Name	City	State
United States	University of Maryland, Baltimore	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Epinephrine Levels		32 weeks