Clinical Trial: Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: Yale University

Current Primary Outcome:

  • Glucose (mg/dL) [ Time Frame: End of study (up to 240 minutes) ]
    Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
  • Glucose Infusion Rate (mg/kg.Min) [ Time Frame: End of study (up to 240 minutes) ]
    The glucose infusion rate corresponds to the amount of 20% dextrose given during the hyperinsulinemic-hypoglycemic clamp study, necessary to keep blood glucose levels at the target range (50-55 mg/dL).


Original Primary Outcome: Hormone Levels [ Time Frame: 240 minutes ]

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.


Current Secondary Outcome:

  • Glucagon (pg/mL) [ Time Frame: End of study (up to 240 minutes) ]
    Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
  • Cortisol (ug/dL) [ Time Frame: End of study (up to 240 minutes) ]
    Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
  • Epinephrine (pg/mL) [ Time Frame: End of study (up to 240 minutes) ]
    Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
  • Norepinephrine (pg/mL) [ Time Frame: End of study (up to 240 minutes) ]
    Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.


Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: October 26, 2011
Date Started: August 2011
Date Completion:
Last Updated: February 17, 2016
Last Verified: February 2016