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Naltrexone and Hypoglycemia in Type 1 Diabetes

This study is currently recruiting participants.
Verified by University of Minnesota - Clinical and Translational Science Institute, September 2010
First Received: January 19, 2010 Last Updated: September 27, 2010 

Sponsor:
University of Minnesota - Clinical and Translational Science Institute
Collaborators:
 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) American Diabetes Association
Information provided by:
 University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT01053078

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 I
Phase II

Study Type: Interventional
Study Design: Allocation: Randomized
Control: Placebo Control
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

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

Naltrexone: Placebo Comparator
Double blind placebo comparable
Interventions:

  • Drug: Naltrexone
  • Drug: Naltrexone
 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: Placebo Comparator
Interventions:

  • Drug: Naltrexone
  • Drug: Naltrexone

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

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