Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

December 10, 2014 updated by: Steve Davis, Vanderbilt University

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Catecholamine levels
Time Frame: Comparative study performed every 6-8 weeks
Comparative study performed every 6-8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

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

Investigators

  • Principal Investigator: Stephen N Davis, MD, Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

January 1, 2008

First Submitted That Met QC Criteria

January 1, 2008

First Posted (Estimate)

January 14, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#040908-HAAF-T1DM-Q2
  • DK69803

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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