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Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Sponsor
Vanderbilt University (Other)
Overall Status
Completed
CT.gov ID
NCT00592332
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
56
Enrollment
1
Location
2
Arms
48
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated 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 :
Jun 1, 2005
Actual Primary Completion Date :
Jun 1, 2007
Actual Study Completion Date :
Jun 1, 2009

Arms and Interventions

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 Names:
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Catecholamine levels [Comparative study performed every 6-8 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    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 ยท 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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steve Davis, Department Chair, Vanderbilt University
    ClinicalTrials.gov Identifier:
    NCT00592332
    Other Study ID Numbers:
    • IRB#040908-HAAF-T1DM-Q2
    • DK69803
    First Posted:
    Jan 14, 2008
    Last Update Posted:
    Dec 11, 2014
    Last Verified:
    Dec 1, 2014
    Additional relevant MeSH terms:
    Pure Autonomic Failure
    Hypoglycemia
    Alprazolam

    Study Results

    No Results Posted as of Dec 11, 2014