Type 1 DiabetesNCT00592332
Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
A study testing Alprazolam in people with Type 1 Diabetes, run by Vanderbilt University at 1 site in United States.
Trial summary
Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Alprazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Jun 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- Subjects taking steroids
- Subjects taking beta blockers
- Subjects on anticoagulant drugs, anemic, or with known bleeding diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2
Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.
Read the 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
- Being tested
- Alprazolam, control group
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlprazolamDrug
Also called Xanax
1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
control groupOther
control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1. Receives: Drug: Alprazolam |
| 1 | Experimental | Hyperinsulinemic glucose clamp in group with no drug. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catecholamine levels
Measured: Comparative study performed every 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJun 2005
- Primary completionJun 2007
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steve Davis, Vanderbilt University
- Investigators
- Stephen N Davis, MD, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00592332
- Sponsor's protocol ID
- IRB#040908-HAAF-T1DM-Q2
- Other IDs
- DK69803
- Status last verified
- Dec 2014
- First submitted
- 1 Jan 2008
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2
- ClinicalTrials.gov ID
- NCT00592332
- Acronym / sponsor ID
- IRB#040908-HAAF-T1DM-Q2
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Jun 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Drug: AlprazolamHyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1. |
| 1 | Experimental | Other: control groupHyperinsulinemic glucose clamp in group with no drug. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlprazolamAlso: Xanax1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2) | Drug | 2 |
| control groupcontrol group is two hyperinsulinemic glucose clamps on day 1 with no drug given. | Other | 1 |
Primary outcome
Catecholamine levels
Time frame: Comparative study performed every 6-8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen N Davis, MD principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alprazolam in people with Type 1 Diabetes, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catecholamine levels (time frame: Comparative study performed every 6-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.