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Naltrexone and Hypoglycemia in Type 1 Diabetes (Naltrexone)

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. Identifier: NCT01053078
Recruitment Status : Completed
First Posted : January 21, 2010
Results First Posted : September 12, 2014
Last Update Posted : February 5, 2020
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
Information provided by (Responsible Party):
University of Minnesota

Brief Summary:

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 or disease Intervention/treatment Phase
Type 1 Diabetes Hypoglycemia Unawareness Drug: Naltrexone Other: Placebo Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Naltrexone Drug: Naltrexone
1 month treatment; Naltrexone 25mg once daily for 5 days, then 50 mg once daily for 23 days
Other Name: ReVia

Placebo Comparator: Placebo Other: Placebo
1 month treatment; placebo tablet once daily for 28 days

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

Secondary Outcome Measures :
  1. Hypoglycemia Symptom Score [ Time Frame: 1 month ]
    Hypoglycemia symptom score is determined by a standardized 12-item questionnaire. Participants rank hypoglycemic symptoms on a Likert scale from 0 (no symptoms) to 6 (severe symptoms). Total score is a sum of the 12 items scores with a total score range from 0 to 72. Higher scores indicated increased severity of symptoms associated with hypoglycemia.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01053078

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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
American Diabetes Association
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Principal Investigator: Elizabeth R Seaquist, MD University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University of Minnesota Identifier: NCT01053078    
Other Study ID Numbers: 0903M60907
R01DK062440 ( U.S. NIH Grant/Contract )
7-09-DCS-02 ( Other Grant/Funding Number: American Diabetes Association )
First Posted: January 21, 2010    Key Record Dates
Results First Posted: September 12, 2014
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
Type 1 diabetes
Hypoglycemia unawareness
low blood sugar
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents