Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Vanderbilt University.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Vanderbilt University
Collaborator:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00592332
First received: January 1, 2008
Last updated: December 18, 2008
Last verified: December 2008
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Purpose
Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.
| Condition | Intervention |
|---|---|
|
Type 1 Diabetes |
Drug: Alprazolam Other: control group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Subject) |
| Official Title: | Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2 |
Resource links provided by NLM:
Genetics Home Reference related topics:
type 1 diabetes
Drug Information available for:
Alprazolam
U.S. FDA Resources
Further study details as provided by Vanderbilt University:
Primary Outcome Measures:
- Catecholamine levels [ Time Frame: Comparative study performed every 6-8 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 56 |
| Study Start Date: | June 2005 |
| Estimated Study Completion Date: | June 2009 |
| Estimated Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 2
Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.
|
Drug: Alprazolam
1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
Other Name: Xanax
|
|
Experimental: 1
Hyperinsulinemic glucose clamp in group with no drug.
|
Other: control group
control group is two hyperinsulinemic glucose clamps on day 1 with no drug given.
|
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| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592332
Locations
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
Sponsors and Collaborators
Vanderbilt University
Investigators
| Principal Investigator: | Stephen N Davis, MD | Vanderbilt University |
More Information
No publications provided
| Responsible Party: | Stephen N. Davis, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00592332 History of Changes |
| Other Study ID Numbers: | IRB#040908-HAAF-T1DM-Q2, DK69803 |
| Study First Received: | January 1, 2008 |
| Last Updated: | December 18, 2008 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus, Type 1 Hypoglycemia Pure Autonomic Failure Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases Alprazolam |
Hypnotics and Sedatives Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013