---
title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
nct_id: NCT00592332
overall_status: COMPLETED
phase: NA
sponsor: Vanderbilt University
study_type: INTERVENTIONAL
primary_condition: Type 1 Diabetes
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00592332.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00592332"
ct_last_update_post_date: 2014-12-11
last_seen_at: "2026-05-12T07:24:50.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2

**Official Title:** Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2

**NCT ID:** [NCT00592332](https://clinicaltrials.gov/study/NCT00592332)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 56
- **Lead Sponsor:** Vanderbilt University
- **Collaborators:** National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- **Conditions:** Type 1 Diabetes
- **Start Date:** 2005-06
- **Completion Date:** 2009-06
- **CT.gov Last Update:** 2014-12-11

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 45 Years
- **Sex:** ALL
- **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
```

## Arms

- **2** (EXPERIMENTAL) — Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.
- **1** (EXPERIMENTAL) — Hyperinsulinemic glucose clamp in group with no drug.

## Interventions

- **Alprazolam** (DRUG) — 1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
- **control group** (OTHER) — control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.

## Primary Outcomes

- **Catecholamine levels** _(time frame: Comparative study performed every 6-8 weeks)_

## Locations (1)

- Vanderbilt University, Nashville, Tennessee, United States

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.vanderbilt university|nashville|tennessee|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00592332.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00592332*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*