Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Overview

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

Full Title of Study: “Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2007

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.

Interventions

  • Drug: Alprazolam
    • 1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
  • Other: control group
    • control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.

Arms, Groups and Cohorts

  • Experimental: 2
    • Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.
  • Experimental: 1
    • Hyperinsulinemic glucose clamp in group with no drug.

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 45 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Vanderbilt University
  • Collaborator
    • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Steve Davis, Department Chair – Vanderbilt University
  • Overall Official(s)
    • Stephen N Davis, MD, Principal Investigator, Vanderbilt University

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