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Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01462227
First received: October 26, 2011
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention
Hypoglycemia
Drug: Naltrexone High Dose
Drug: Naltrexone Low Dose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Opiate Blockade With Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • Glucose (mg/dL) [ Time Frame: End of study (up to 240 minutes) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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:
  • Glucagon (pg/mL) [ Time Frame: End of study (up to 240 minutes) ] [ Designated as safety issue: No ]
    Glucagon was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

  • Cortisol (ug/dL) [ Time Frame: End of study (up to 240 minutes) ] [ Designated as safety issue: No ]
    Cortisol was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

  • Epinephrine (pg/mL) [ Time Frame: End of study (up to 240 minutes) ] [ Designated as safety issue: No ]
    Epinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.

  • Norepinephrine (pg/mL) [ Time Frame: End of study (up to 240 minutes) ] [ Designated as safety issue: No ]
    Norepinephrine was measured in the blood throughout the hyperinsulinemic-hypoglycemic clamp study.


Enrollment: 17
Study Start Date: August 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Naltrexone High Dose
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.
Drug: Naltrexone Low Dose
Naltrexone 50mg for two administrations.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462227

Locations
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Robert Sherwin, MD Yale School of Medicine
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01462227     History of Changes
Other Study ID Numbers: HIC1006006927 
Study First Received: October 26, 2011
Results First Received: January 20, 2016
Last Updated: February 17, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Hypoglycemia
Type 1 diabetes

Additional relevant MeSH terms:
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2016