Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Hypoglycemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462227
• Other study ID #: HIC1006006927
• Status: Completed
• Phase: N/A
• First received: October 26, 2011
• Last updated: February 17, 2016
• Start date: August 2011
• Est. completion date: October 2013

Study information

• Verified date: February 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes (well controlled, 2-3 hypoglycemic episodes/wk) age 18-55, BMI 18-35

Exclusion Criteria:

• pregnancy

• significant diabetes complications

• liver disease, cirrhosis

• cardiac disease

• neurological disorder

• autonomic neuropathy

• kidney disease

• lactose intolerance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• Naltrexone High Dose
Naltrexone 100mg for two administrations.
• Naltrexone Low Dose
Naltrexone 50mg for two administrations.

Locations

Country	Name	City	State
United States	Yale School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glucose (mg/dL)	Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.	End of study (up to 240 minutes)	No
Primary	Glucose Infusion Rate (mg/kg.Min)	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).	End of study (up to 240 minutes)	No
Secondary	Glucagon (pg/mL)	Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.	End of study (up to 240 minutes)	No
Secondary	Cortisol (ug/dL)	Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.	End of study (up to 240 minutes)	No
Secondary	Epinephrine (pg/mL)	Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.	End of study (up to 240 minutes)	No
Secondary	Norepinephrine (pg/mL)	Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.	End of study (up to 240 minutes)	No