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Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

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ClinicalTrials.gov Identifier: NCT01462227
Recruitment Status : Completed
First Posted : October 31, 2011
Results First Posted : February 18, 2016
Last Update Posted : February 18, 2016
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University

October 26, 2011
October 31, 2011
January 20, 2016
February 18, 2016
February 18, 2016
August 2011
October 2013   (Final data collection date for primary outcome measure)
  • Glucose (mg/dL) [ Time Frame: 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) [ 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).
Hormone Levels [ Time Frame: 240 minutes ]
Glucagon and catecholamine levels will be measured throughout the study to assess whether there are changes during hypoglycemia with naltrexone. These levels will be checked every 30 minutes during the 240 minute study session.
Complete list of historical versions of study NCT01462227 on ClinicalTrials.gov Archive Site
  • Glucagon (pg/mL) [ Time Frame: End of study (up to 240 minutes) ]
    Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
  • Cortisol (ug/dL) [ Time Frame: End of study (up to 240 minutes) ]
    Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
  • Epinephrine (pg/mL) [ Time Frame: End of study (up to 240 minutes) ]
    Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
  • Norepinephrine (pg/mL) [ Time Frame: End of study (up to 240 minutes) ]
    Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.
Not Provided
Not Provided
Not Provided
 
Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypoglycemia
  • Drug: Naltrexone High Dose
    Naltrexone 100mg for two administrations.
  • Drug: Naltrexone Low Dose
    Naltrexone 50mg for two administrations.
  • 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.
    Intervention: Drug: Naltrexone High Dose
  • 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.
    Intervention: Drug: Naltrexone Low Dose
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
15
October 2013
October 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01462227
HIC1006006927
No
Not Provided
Not Provided
Yale University
Yale University
National Institutes of Health (NIH)
Principal Investigator: Robert Sherwin, MD Yale School of Medicine
Yale University
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP