Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00592332
First received: January 1, 2008
Last updated: December 18, 2008
Last verified: December 2008
  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

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

Resource links provided by NLM:


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
Experimental: 2
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)
Other Name: Xanax
Experimental: 1
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
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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
Investigators
Principal Investigator: Stephen N Davis, MD Vanderbilt University
  More Information

No publications provided

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

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hypoglycemia
Pure Autonomic Failure
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Primary Dysautonomias
Autonomic Nervous System Diseases
Nervous 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 July 24, 2014