Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00592332

Enrollment

Registered

2008-01-14

Start date

2005-06-30

Completion date

2009-06-30

Last updated

2014-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

Interventions

DRUGAlprazolam

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

OTHERcontrol group

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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 · 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

Design outcomes

Primary

Measure	Time frame
Catecholamine levels	Comparative study performed every 6-8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026