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Naltrexone and Hypoglycemia in Type 1 Diabetes

This study is currently recruiting participants.
Verified August 2011 by University of Minnesota - Clinical and Translational Science Institute
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01053078
First received: January 19, 2010
Last updated: August 30, 2011
Last verified: August 2011
History of Changes
  Purpose

Low blood sugar is also called hypoglycemia. Usually, it is mild and can be treated quickly and easily by eating or drinking a small amount of a sugar-rich food. If low blood sugar is left untreated, it can get worse and cause confusion, clumsiness or fainting. Severe hypoglycemia can lead to seizures, coma, and even death.

Some people with diabetes do not have early warning signs of low blood sugar. This condition is called hypoglycemia unawareness. It happens when the body stops reacting to low blood sugar levels and the person does not realize that they need to treat their hypoglycemia. This can lead to more severe and dangerous hypoglycemia.

The purpose of this early study is to see if a drug called naltrexone should be studied more in people with Type I diabetes and hypoglycemia unawareness. This study will show whether naltrexone could reduce hypoglycemia unawareness. The study will also show, by using magnetic resonance imaging (also called MRI), whether naltrexone changes the way blood flows in the brain when a person is experiencing hypoglycemia.


Condition Intervention Phase
Type 1 Diabetes
Hypoglycemia Unawareness
 Drug: Naltrexone
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effect of Naltrexone on Cerebral Blood Flow and Hypoglycemia in Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Cerebral blood flow [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of hypoglycemia [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Naltrexone
Double blind placebo comparable
 Drug: Naltrexone
1 month treatment
Other Name: ReVia
Drug: Naltrexone
Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28
Placebo Comparator: Placebo Drug: Naltrexone
1 month treatment
Other Name: ReVia
Drug: Naltrexone
Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-65 years of age
  • Type 1 diabetes
  • Hypoglycemia unawareness
  • Capable of providing informed consent

Exclusion Criteria:

  • Concomitant regular use of acetaminophen, aspirin or ibuprofen
  • History of drug or alcohol abuse
  • Psychiatric illness
  • Elevations in ALT/AST, creatinine or history of hepatitis, liver failure, or renal failure/insufficiency
  • Pregnant or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01053078

Contacts
Contact: Anjali Kumar, PA-C, MPAS 612-624-0470 kumar045@umn.edu

Locations
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Anjali Kumar, PA-C, MPAS     612-624-0470     kumar045@umn.edu    
Principal Investigator: Elizabeth R Seaquist, MD            
Sub-Investigator: Silvia Mangia, PhD            
Sub-Investigator: Anjali Kumar, PA-C, MPAS            
Sub-Investigator: Monica Stiles, MD            
Sub-Investigator: Nolawit Tesfaye, MD            
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Investigators
Principal Investigator: Elizabeth R Seaquist, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01053078     History of Changes
Other Study ID Numbers: Protocol 10087, R01DK062440, 7-09-DCS-02
Study First Received: January 19, 2010
Last Updated: August 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Type 1 diabetes
Hypoglycemia unawareness
low blood sugar

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Unconsciousness
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 May 23, 2013