Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2 - Full Text View

Sponsors and Collaborators:	Vanderbilt University National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00592332

Purpose

Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.

Condition	Intervention
Type 1 Diabetes	Drug: Alprazolam Other: control group

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Dextrose Alprazolam

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Subject), Active Control, Crossover Assignment
Official Title:	Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Catecholamine levels [ Time Frame: Comparative study performed every 6-8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	56
Study Start Date:	June 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.	Drug: Alprazolam 1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
1: Experimental Hyperinsulinemic glucose clamp in group with no drug.	Other: control group control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.

Detailed Description:

Due to the fundamental importance of glucose as a cerebral fuel, a complex and redundant counterregulatory response to hypoglycemia exists in man. Some studies have shown that prior activation of GABA(A) receptors may result in blunting of counterregulatory responses during next day hypoglycemia.

The Specific Aim is to determine if repeated activation of GABA(A) receptors using Alprazolam will result in blunting of neuroendocrine, ANS and metabolic counterregulatory mechanisms during next day hypoglycemia in T1DM and healthy man.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

16 (8 males, 8 females) Type 1 diabetes patients aged 18-45 yr.
16 (8 males, 8 females) healthy controls aged 18-45 yr.
HbA1c > 7.0% (Type 1 diabetes patients)
Had diabetes for 2-15 years (Type 1 diabetes patients)
No clinical evidence of diabetic tissue complications (Type 1 diabetes patients)
Body mass index 21-30 kg · m-2
Normal bedside autonomic function
Normal results of routine blood test to screen for hepatic, renal, and hematological abnormalities
Female volunteers of childbearing potential: negative HCG pregnancy test

Exclusion Criteria:

Prior history of poor health: any current or prior disease condition that alters carbohydrate metabolism and prior cardiac events and/or evidence for cardiac disease
Hemoglobin of less than 12 g/dl
Abnormal results following screening tests
Pregnancy
Subjects unable to give voluntary informed consent
Subjects with known liver or kidney disease
Subjects taking steroids
Subjects taking beta blockers
Subjects on anticoagulant drugs, anemic, or with known bleeding diseases

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00592332

Locations

United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Stephen N Davis, MD

Vanderbilt University

More Information

Responsible Party:	Vanderbilt University ( Stephen N. Davis )
Study ID Numbers:	IRB#040908-HAAF-T1DM-Q2, DK69803
Study First Received:	January 1, 2008
Last Updated:	December 18, 2008
ClinicalTrials.gov Identifier:	NCT00592332
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Alprazolam
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Pharmacologic Actions
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009