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Type 1 Diabetes | Naltrexone and Hypoglycemia in Type 1 Diabetes

Type 1 Diabetes research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Type 1 Diabetes

Hypoglycemia Unawareness

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Naltrexone1 month treatment

Drug:NaltrexoneNaltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

NaltrexoneDouble blind placebo comparable

Placebo

Study Status

Completed

Start Date: October 2009

Completed Date: June 2014

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Cerebral Blood Flow

Secondary Outcome: Rates of Hypoglycemia

Study sponsors, principal investigator, and references

Principal Investigator: Elizabeth R Seaquist, MD

Lead Sponsor: University of Minnesota - Clinical and Translational Science Institute

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More information:https://clinicaltrials.gov/show/NCT01053078

Discuss Hypoglycaemia