Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Not Applicable

Completed

• Conditions: Hypoglycemia
• Interventions: Drug: Naltrexone High Dose; Drug: Naltrexone Low Dose

• Registration Number: NCT01462227
• Lead Sponsor: Yale University

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 Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-28
• Study First Posted: 2011-10-31
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Results First Submitted: 2016-01-20
• Status Verified: 2016-02
• Results First Submitted QC: 2016-02-17
• Last Update Submitted: 2016-02-17
• Results First Posted: 2016-02-18
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

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Exclusion Criteria

• pregnancy
• significant diabetes complications
• liver disease, cirrhosis
• cardiac disease
• neurological disorder
• autonomic neuropathy
• kidney disease
• lactose intolerance

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Naltrexone (higher dose)	Naltrexone High 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.
Naltrexone (lower dose)	Naltrexone Low 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.

Primary Outcome Measures

Name	Time	Method
Glucose (mg/dL)	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)	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).

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yale School of Medicine; 🇺🇸 New Haven, Connecticut, United States