NCT01462227

Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hypoglycemia

Interventions

Type	Name	Description
DRUG	Naltrexone High Dose	Naltrexone 100mg for two administrations.
DRUG	Naltrexone Low Dose	Naltrexone 50mg for two administrations.

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2011-10-31
• Last updated: 2016-02-18
• Results posted: 2016-02-18

Locations

1 site across 1 country: United States