Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Purpose
Insulin treatment often causes the blood glucose levels to fall too low. The body usually responds to low blood glucose levels by releasing hormones which act against the insulin to help correct the low blood glucose levels. However, this hormone response can be altered in people with diabetes. Currently there are no therapeutic agents that can be used to improve the recovery from hypoglycemia (low blood sugar). Naltrexone is a tablet used to help people who are addicted to alcohol or morphine-based drugs to remain drug and alcohol-free but it can also affect the levels of the hormones which are released during hypoglycemia. The aim of this study is to determine whether naltrexone can be used to improve and accelerate the recovery from hypoglycemia in patients with type 1 diabetes.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment Official Title: The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Further study details as provided by Yale University:
Primary Outcome Measures:
Hormone Levels [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]

Glucagon and catecholamine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with naltrexone. These levels will be checked every 30 minutes during the 240 minute study session.

Estimated Enrollment: 15
Study Start Date: August 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

Intervention Details:
Drug: Naltrexone
Naltrexone 100mg for two administrations.