Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00574639

Acronym

Alp Ex

Enrollment

Registered

2007-12-17

Start date

2007-07-31

Completion date

2016-06-30

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes, Alprazolam, Exercise

Brief 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.

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.

Interventions

DRUGAlprazolam

1 mg given orally prior to morning and afternoon clamps on Day 1

DRUGPlacebo

1 mg given orally prior to glucose clamps on Day 1 (morning and afternoon)

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Change in Epinephrine Levels	32 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026