Mechanisms of Hypoglycemia Associated Autonomic Dysfunction Question 2 - Full Text View

Sponsor:	University of Maryland
Collaborator:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	University of Maryland
ClinicalTrials.gov Identifier:	NCT00574639

Purpose

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.

Condition	Intervention
Type 1 Diabetes	Drug: Alprazolam Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Factorial Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Mechanisms of Hypoglycemia-Associated Autonomic Dysfunction. The Effect of Alprazolam on Exercise Induced Hypoglycemia.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Anxiety Diabetes Medicines Diabetes Type 1 Exercise and Physical Fitness Hypoglycemia

Drug Information available for: Alprazolam

U.S. FDA Resources

Further study details as provided by University of Maryland:

Primary Outcome Measures:

Change in Epinephrine Levels [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	28
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: 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 Name: 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)

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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 Exclusion Criteria according to protocol

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574639

Contacts

Contact: Donna B. Tate, MS

410-706-5642

dtate@medicine.umaryland.edu

Locations

United States, Maryland
University of Maryland, Baltimore	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Donna B. Tate, MS 410-706-5642
Principal Investigator: Stephen N. Davis, MD

Sponsors and Collaborators

University of Maryland

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Stephen N. Davis, MD

University of Maryland

More Information

No publications provided

Responsible Party:	Stephen N. Davis, MD, University of Maryland, Baltimore
ClinicalTrials.gov Identifier:	NCT00574639 History of Changes
Other Study ID Numbers:	HP-00044868, HL056693
Study First Received:	December 13, 2007
Last Updated:	July 31, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Maryland:

Type 1 Diabetes
Alprazolam
Exercise

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Alprazolam
Hypnotics and Sedatives
Central Nervous System Depressants

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012