Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00592332
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : December 11, 2014
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Steve Davis, Vanderbilt University

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

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Drug: Alprazolam Other: control group Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2
Study Start Date : June 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Alprazolam

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Catecholamine levels [ Time Frame: Comparative study performed every 6-8 weeks ]

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00592332

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)
Principal Investigator: Stephen N Davis, MD Vanderbilt University

Responsible Party: Steve Davis, Department Chair, Vanderbilt University Identifier: NCT00592332     History of Changes
Other Study ID Numbers: IRB#040908-HAAF-T1DM-Q2
First Posted: January 14, 2008    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
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
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action