Naltrexone and Hypoglycemia in Type 1 Diabetes (Naltrexone)
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|ClinicalTrials.gov Identifier: NCT01053078|
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : September 12, 2014
Last Update Posted : February 5, 2020
Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death.
Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia.
The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Hypoglycemia Unawareness||Drug: Naltrexone Other: Placebo||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Study of the Effect of Naltrexone on Cerebral Blood Flow and Hypoglycemia in Type 1 Diabetes Mellitus|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||June 2014|
|Actual Study Completion Date :||June 2014|
1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
Other Name: ReVia
|Placebo Comparator: Placebo||
1 month treatment; placebo tablet once daily for 28 days
- Cerebral Blood Flow [ Time Frame: 1 month ]
- Hypoglycemia Symptom Score [ Time Frame: 1 month ]Hypoglycemia symptom score is determined by a standardized 12-item questionnaire. Participants rank hypoglycemic symptoms on a Likert scale from 0 (no symptoms) to 6 (severe symptoms). Total score is a sum of the 12 items scores with a total score range from 0 to 72. Higher scores indicated increased severity of symptoms associated with hypoglycemia.
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): NCT01053078
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Elizabeth R Seaquist, MD||University of Minnesota|