Amir Moheet1, Silvia Mangia2, Anjali Kumar3, Nolawit Tesfaye3, Lynn E Eberly4, Yun Bai4, Kristine Kubisiak4, Elizabeth R Seaquist3. 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.
RCT Entities:
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.
Authors: Paul A Harris; Robert Taylor; Robert Thielke; Jonathon Payne; Nathaniel Gonzalez; Jose G Conde Journal: J Biomed Inform Date: 2008-09-30 Impact factor: 6.317
Authors: C Fanelli; S Pampanelli; L Epifano; A M Rambotti; A Di Vincenzo; F Modarelli; M Ciofetta; M Lepore; B Annibale; E Torlone Journal: Diabetologia Date: 1994-12 Impact factor: 10.122
Authors: Petr Bednarik; Amir A Moheet; Heidi Grohn; Anjali F Kumar; Lynn E Eberly; Elizabeth R Seaquist; Silvia Mangia Journal: Front Neurosci Date: 2017-09-25 Impact factor: 4.677