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J Diabetes Complications. 2015 Nov-Dec;29(8):1277-82. doi: 10.1016/j.jdiacomp.2015.08.004. Epub 2015 Aug 12.

Naltrexone for treatment of impaired awareness of hypoglycemia in type 1 diabetes: A randomized clinical trial.

Author information

1
Division of Endocrinology and Diabetes, Department of Medicine, University of Minnesota, Minneapolis, MN, United States. Electronic address: mohee002@umn.edu.
2
Center for Magnetic Resonance Research, Department of Radiology, University of Minnesota, Minneapolis, MN, United States.
3
Division of Endocrinology and Diabetes, Department of Medicine, University of Minnesota, Minneapolis, MN, United States.
4
Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, United States.

Abstract

AIMS:

Impaired awareness of hypoglycemia (IAH) is a limiting factor in the treatment of type 1 diabetes (T1D) and is a challenging condition to reverse. The objective of this study was to test the hypothesis that naltrexone therapy in subjects with T1D and IAH will improve counterregulatory hormone response and recognition of hypoglycemia symptoms during hypoglycemia.

METHODS:

We performed a pilot randomized double blind trial of 4weeks of naltrexone therapy (n=10) or placebo (n=12) given orally in subjects with T1D and IAH. Outcome measures included hypoglycemia symptom scores, counterregulatory hormone levels and thalamic activation as measured by cerebral blood flow using MRI during experimental hypoglycemia in all subjects before and after 4weeks of intervention.

RESULTS:

After 4weeks of therapy with naltrexone or placebo, no significant differences in response to hypoglycemia were seen in any outcomes of interest within each group.

CONCLUSIONS:

In this small study, short-term treatment with naltrexone did not improve recognition of hypoglycemia symptoms or counterregulatory hormone response during experimental hypoglycemia in subjects with T1D and IAH. Whether this lack of effect is related to the small sample size or due to the dose, the advanced stage of study population or the drug itself should be the subject of future investigation.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT01053078.

KEYWORDS:

HAAF; Hypoglycemia; Impaired awareness of hypoglycemia; Naltrexone; Opioid antagonists; Type 1 diabetes

PMID:
26345338
PMCID:
PMC4871128
DOI:
10.1016/j.jdiacomp.2015.08.004
[Indexed for MEDLINE]
Free PMC Article

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