NCT00574639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started Jul 2007

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 17, 2007

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 12, 2019

Status Verified

September 1, 2019

Enrollment Period

8.9 years

First QC Date

December 13, 2007

Last Update Submit

September 10, 2019

Conditions

Type 1 Diabetes

Keywords

Type 1 DiabetesAlprazolamExercise

Outcome Measures

Primary Outcomes (1)

  • Change in Epinephrine Levels

    32 weeks

Study Arms (4)

Arm 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.

Drug: Alprazolam

Arm 2

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.

Drug: Placebo

Arm 3

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.

Drug: Alprazolam

Arm 4

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.

Drug: Placebo

Interventions

AlprazolamDRUG

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

Also known as: Xanax
Arm 1Arm 3
PlaceboDRUG

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

Arm 2Arm 4

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 DM patients (7 male and 7 female) aged 18-50 years
  • HBA1c \> 6%
  • BMI\<35 kg/m2
  • healthy individuals (7 male and 7 female) aged 18-50 years, BMI matched

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (1)

  • Hedrington MS, Tate DB, Younk LM, Davis SN. Effects of Antecedent GABA A Receptor Activation on Counterregulatory Responses to Exercise in Healthy Man. Diabetes. 2015 Sep;64(9):3253-61. doi: 10.2337/db15-0212. Epub 2015 Apr 21.

    PMID: 25901095DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Interventions

Alprazolam

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

BenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Stephen N. Davis, MD

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 13, 2007

First Posted

December 17, 2007

Study Start

July 1, 2007

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 12, 2019

Record last verified: 2019-09

Locations

US(1)