Overview

This trial is active, not recruiting.

Condition type 1 diabetes
Treatments alprazolam, placebo
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model factorial assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
Day 1 study two hyperinsulinemic (high Insulin dose) euglycemic (normal glucose level) clamps x 2. Day 2 exercise for 90 minutes on recumbent bike. Patient randomized to placebo or Xanax (Alprazolam) drug on Day 1 to receive 1 mg orally prior to each clamp.
alprazolam Xanax
1 mg given orally prior to morning and afternoon clamps on Day 1
(Experimental)
Day 1 study two hyperinsulinemic (high Insulin dose) euglycemic (normal glucose level) clamps x 2. Day 2 exercise for 90 minutes on recumbent bike. Patient randomized to placebo or Xanax (Alprazolam) drug on Day 1 to receive 1 mg orally prior to each clamp.
placebo
1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)
(Experimental)
Day 1 study two hyperinsulinemic (high Insulin dose) hypoglycemic (low glucose level) clamps x 2. Day 2 exercise for 90 minutes on recumbent bike. Patient randomized to placebo or Xanax (Alprazolam) drug on Day 1 to receive 1 mg orally prior to each clamp.
alprazolam Xanax
1 mg given orally prior to morning and afternoon clamps on Day 1
(Experimental)
Day 1 study two hyperinsulinemic (high Insulin dose) hypoglycemic (low glucose level) clamps x 2. Day 2 exercise for 90 minutes on recumbent bike. Patient randomized to placebo or Xanax (Alprazolam) drug on Day 1 to receive 1 mg orally prior to each clamp.
placebo
1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)

Primary Outcomes

Measure
Change in Epinephrine Levels
time frame: 32 weeks

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Maryland.