Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2 (Alp Ex)

September 10, 2019 updated by: Stephen N. Davis, MBBS, University of Maryland, Baltimore

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland, Baltimore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1
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.
Drug: Alprazolam
1 mg given orally prior to morning and afternoon clamps on Day 1
Other Names:
  • Xanax
Experimental: Arm 2
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.
Drug: Placebo
1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)
Experimental: Arm 3
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.
Drug: Alprazolam
1 mg given orally prior to morning and afternoon clamps on Day 1
Other Names:
  • Xanax
Experimental: Arm 4
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.
Drug: Placebo
1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Epinephrine Levels
Time Frame: 32 weeks
32 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Maryland, Baltimore

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 13, 2007

First Submitted That Met QC Criteria

December 13, 2007

First Posted (Estimate)

December 17, 2007

Study Record Updates

Last Update Posted (Actual)

September 12, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HP-00044868
  • HL056693

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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