- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01462227
Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
February 17, 2016 updated by: Yale University
The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
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New Haven, Connecticut, United States, 06520
- Yale School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Naltrexone 100mg for two administrations.
|
Experimental: 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.
|
Naltrexone 50mg for two administrations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucose (mg/dL)
Time Frame: End of study (up to 240 minutes)
|
Glucose was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
|
End of study (up to 240 minutes)
|
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).
|
End of study (up to 240 minutes)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glucagon (pg/mL)
Time Frame: End of study (up to 240 minutes)
|
Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
|
End of study (up to 240 minutes)
|
Cortisol (ug/dL)
Time Frame: End of study (up to 240 minutes)
|
Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
|
End of study (up to 240 minutes)
|
Epinephrine (pg/mL)
Time Frame: End of study (up to 240 minutes)
|
Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
|
End of study (up to 240 minutes)
|
Norepinephrine (pg/mL)
Time Frame: End of study (up to 240 minutes)
|
Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
|
End of study (up to 240 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Sherwin, MD, Yale School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
October 26, 2011
First Submitted That Met QC Criteria
October 28, 2011
First Posted (Estimate)
October 31, 2011
Study Record Updates
Last Update Posted (Estimate)
February 18, 2016
Last Update Submitted That Met QC Criteria
February 17, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HIC1006006927
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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