Overview

Naltrexone and Hypoglycemia in Type 1 Diabetes

Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Minnesota
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
American Diabetes Association
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Treatments:
Naltrexone
Criteria
Inclusion Criteria:

- 18-65 years of age

- Type 1 diabetes

- Hypoglycemia unawareness

- Capable of providing informed consent

Exclusion Criteria:

- Concomitant regular use of acetaminophen, aspirin or ibuprofen

- History of drug or alcohol abuse

- Psychiatric illness

- Elevations in ALT (Alanine Aminotransferase), AST (Aspartate Aminotransferase),
creatinine or history of hepatitis, liver failure, or renal failure/insufficiency

- Pregnant or breastfeeding