Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Yale University

Status: Completed

Conditions: Hypoglycemia

Treatments: Drug: Naltrexone Low Dose; Drug: Naltrexone High Dose

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01462227

HIC1006006927

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Naltrexone (higher dose)

Experimental group

Description:

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.

Treatment:

Drug: Naltrexone High Dose

Naltrexone (lower dose)

Experimental group

Description:

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.

Treatment:

Drug: Naltrexone Low Dose