Hypoglycemia Associated Autonomic Failure in Type 1 DM
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|ClinicalTrials.gov Identifier: NCT00592670|
Recruitment Status : Completed
First Posted : January 14, 2008
Last Update Posted : December 11, 2014
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Fluoxetine Drug: Placebo||Not Applicable|
Because selective serotonin reuptake inhibitors are commonly prescribed to treat depression, it is vital to understand how these antidepressants affect hypoglycemia- the most feared complication in diabetes. This study's aim is to determine whether individuals who are chronically taking selective serotonin reuptake inhibitors have a reduced ability to defend against hypoglycemia compared to individuals not taking the medication, thus leaving them more susceptible to hypoglycemia. Both healthy volunteers and volunteers with type 1 diabetes mellitus will be studied. The results could potentially be important to diabetic patients, by demonstrating to physicians how to modify therapy for those taking antidepressants in order to avoid hypoglycemia.
The known effects of SSRI on the hypothalamo pituitary axis(HPA)may be important to the counterregulation of hypoglycemia. Prior research has demonstrated in healthy volunteers that antecedent increases in plasma cortisol result in significant blunting of neuroendocrine and autonomic responses to subsequent hypoglycemia. Thus, by activating the HPA axis, SSRIs could cause blunting of the counterregulatory response to hypoglycemia.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Hypoglycemia Associated Autonomic Failure in Type 1 DM, Question 6|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||June 2007|
|Actual Study Completion Date :||October 2008|
Baseline measures followed by a randomized 6 weeks treatment of Prozac.
20 mg fluoxetine orally one per day for 1 week, 40 mg fluoxetine orally once per day for one week, 80 mg Fluoxetine orally for remaining 4 weeks of treatment
Other Name: Prozac
Placebo Comparator: 2
Baseline followed by a 6 week randomized treatment of placebo.
20 mg placebo pill taken orally once per day for one week, 40 mg placebo pill taken orally one per day for one week, 80 mg placebo pill taken orally once per day for remaining 4 weeks.
- Catecholamine measures [ Time Frame: 6 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00592670
|United States, Tennessee|
|Nashville, Tennessee, United States, 37232-0475|
|Principal Investigator:||Stephen N. Davis, MD||Vanderbilt University|