Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
Recruitment status was Active, not recruiting
Alprazolam (Xanax) will blunt the body's ability to defend itself from low blood sugar.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
|Official Title:||Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2|
- Catecholamine levels [ Time Frame: Comparative study performed every 6-8 weeks ] [ Designated as safety issue: No ]
|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)|
Hyperinsulinemic glucose clamp with Xanax given orally at beginning of each 2 hour clamp on day 1.
1 mg alprazolam given orally 60 minutes prior to each 2 hour glucose clamp on day 1 (x2)
Other Name: Xanax
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00592332
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Stephen N Davis, MD||Vanderbilt University|