Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: control group; Drug: Alprazolam

• Registration Number: NCT00592332
• Lead Sponsor: Vanderbilt University

Brief Summary

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

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 Timeline

• Study Start: 2005-06
• Primary Completion: 2007-06
• Study First Submitted: 2008-01-01
• Study First Submitted QC: 2008-01-01
• Study First Posted: 2008-01-14
• Study Completion: 2009-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-10
• Last Update Posted: 2014-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	control group	Hyperinsulinemic glucose clamp in group with no drug.
2	Alprazolam	Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.

Primary Outcome Measures

Name	Time	Method
Catecholamine levels	Comparative study performed every 6-8 weeks

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States