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Naltrexone and Hypoglycemia in Type 1 Diabetes (Naltrexone)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01053078
First Posted: January 21, 2010
Last Update Posted: June 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Single Group Assignment
Masking: Double (Participant, 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:


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

Primary Outcome Measures:
  • Cerebral Blood Flow [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Rates of Hypoglycemia [ Time Frame: 1 month ]

Enrollment: 29
Study Start Date: October 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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 (Alanine Aminotransferase), AST (Aspartate Aminotransferase), creatinine or history of hepatitis, liver failure, or renal failure/insufficiency
  • Pregnant or breastfeeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01053078


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT01053078     History of Changes
Other Study ID Numbers: Protocol 10087
R01DK062440 ( U.S. NIH Grant/Contract )
7-09-DCS-02 ( Other Grant/Funding Number: American Diabetes Association )
First Submitted: January 19, 2010
First Posted: January 21, 2010
Results First Submitted: September 4, 2014
Results First Posted: September 12, 2014
Last Update Posted: June 27, 2016
Last Verified: June 2016

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

Additional relevant MeSH terms:
Hypoglycemia
Diabetes Mellitus
Diabetes Mellitus, Type 1
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
Sensory System Agents
Peripheral Nervous System Agents