Hypoglycemia Associated Autonomic Failure in Type 1 DM, Q2
|ClinicalTrials.gov Identifier: NCT00592332|
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Alprazolam Other: control group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 2|
|Study Start Date :||June 2005|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||June 2009|
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.
- Catecholamine levels [ Time Frame: Comparative study performed every 6-8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592332
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Stephen N Davis, MD||Vanderbilt University|