Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

NCT ID: NCT00592332

Last Updated: 2014-12-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2009-06-30

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: SINGLE

Study Groups

2

Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.

Group Type: EXPERIMENTAL

Alprazolam

Intervention Type: DRUG

1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)

1

Hyperinsulinemic glucose clamp in group with no drug.

Group Type: EXPERIMENTAL

control group

Intervention Type: OTHER

control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.

Interventions

Alprazolam

1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)

Intervention Type: DRUG

control group

control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.

Intervention Type: OTHER

Other Intervention Names

Xanax

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Steve Davis

Department Chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen N Davis, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Locations

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

DK69803

Identifier Type: -

Identifier Source: secondary_id

IRB#040908-HAAF-T1DM-Q2

Identifier Type: -

Identifier Source: org_study_id