Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

NCT ID: NCT01462227

Last Updated: 2016-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-10-31

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.

Conditions

Hypoglycemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Naltrexone (higher dose)

Naltrexone 100mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the high dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm.

Group Type: EXPERIMENTAL

Naltrexone High Dose

Intervention Type: DRUG

Naltrexone 100mg for two administrations.

Naltrexone (lower dose)

Naltrexone 50mg tablets were randomly given on 1 of 2 occassions (the other was placebo). The drug was administered 12 hours and 1 hour orally pre-procedure to participants. Placebo was given to the low dose group on 1 of their 2 visits- the order in which placebo was given was randomized by dosage arm.

Group Type: EXPERIMENTAL

Naltrexone Low Dose

Intervention Type: DRUG

Naltrexone 50mg for two administrations.

Interventions

Naltrexone High Dose

Naltrexone 100mg for two administrations.

Intervention Type: DRUG

Naltrexone Low Dose

Naltrexone 50mg for two administrations.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Sherwin, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

HIC1006006927

Identifier Type: -

Identifier Source: org_study_id