Effect of Naltrexone on Counterregulatory Mechanisms in Hypoglycemia

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01462227
First received: October 26, 2011
Last updated: June 26, 2014
Last verified: June 2014
  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

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:
  • Hormone Levels [ Time Frame: 240 minutes ] [ Designated as safety issue: No ]
    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.


Enrollment: 16
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) Drug: Naltrexone
Naltrexone 100mg for two administrations.
Experimental: Naltrexone (lower dose) Drug: Naltrexone
Naltrexone 100mg for two administrations.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
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
Investigators
Principal Investigator: Robert Sherwin, MD Yale School of Medicine
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01462227     History of Changes
Other Study ID Numbers: HIC1006006927
Study First Received: October 26, 2011
Last Updated: June 26, 2014
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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014