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

Amir Moheet, Silvia Mangia, Anjali Kumar, Nolawit Tesfaye, Lynn E Eberly, Yun Bai, Kristine Kubisiak, Elizabeth R Seaquist

Research output: Contribution to journalArticle

8 Citations (Scopus)

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 4 weeks 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 4 weeks of intervention. Results After 4 weeks 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.

Original languageEnglish (US)
Pages (from-to)1277-1282
Number of pages6
JournalJournal of Diabetes and Its Complications
Volume29
Issue number8
DOIs
StatePublished - Nov 1 2015

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Naltrexone
Type 1 Diabetes Mellitus
Hypoglycemia
Randomized Controlled Trials
Therapeutics
Hormones
Cerebrovascular Circulation
Placebos
Sample Size
Outcome Assessment (Health Care)

Keywords

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

Cite this

Naltrexone for treatment of impaired awareness of hypoglycemia in type 1 diabetes : A randomized clinical trial. / Moheet, Amir; Mangia, Silvia; Kumar, Anjali; Tesfaye, Nolawit; Eberly, Lynn E; Bai, Yun; Kubisiak, Kristine; Seaquist, Elizabeth R.

In: Journal of Diabetes and Its Complications, Vol. 29, No. 8, 01.11.2015, p. 1277-1282.

Research output: Contribution to journalArticle

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AU - Kubisiak, Kristine

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