Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study

Doron Garfinkel1, Mariana Zorin2, Julio Wainstein2, Zipora Matas3, Moshe Laudon4, Nava Zisapel4,51Geriatric Palliative Department, Shoham Geriatric Medical Center, Pardes Hana, Israel; 2Diabetes Unit, 3Biochemistry Laboratory, The E Wolfson Medical Center, Holon, Israel; 4Neurim Pharmaceuticals Ltd,...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Garfinkel D, Zorin M, Wainstein J, Matas Z, Laudon M, Zisapel N
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Specialties of internal medicine RC581-951
Acceso en línea:	https://doaj.org/article/d5204dc4b68d4c1cadce845792db1968
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:d5204dc4b68d4c1cadce845792db1968
record_format	dspace
spelling	oai:doaj.org-article:d5204dc4b68d4c1cadce845792db19682021-12-02T07:19:10ZEfficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study1178-7007https://doaj.org/article/d5204dc4b68d4c1cadce845792db19682011-08-01T00:00:00Zhttp://www.dovepress.com/efficacy-and-safety-of-prolonged-release-melatonin-in-insomnia-patient-a8009https://doaj.org/toc/1178-7007Doron Garfinkel1, Mariana Zorin2, Julio Wainstein2, Zipora Matas3, Moshe Laudon4, Nava Zisapel4,51Geriatric Palliative Department, Shoham Geriatric Medical Center, Pardes Hana, Israel; 2Diabetes Unit, 3Biochemistry Laboratory, The E Wolfson Medical Center, Holon, Israel; 4Neurim Pharmaceuticals Ltd, 5Department of Neurobiology, Tel Aviv University, Tel Aviv, IsraelBackground: Diabetes is a major comorbidity in insomnia patients. The efficacy and safety of prolonged-release melatonin 2 mg in the treatment of glucose, lipid metabolism, and sleep was studied in 36 type 2 diabetic patients with insomnia (11 men, 25 women, age 46&ndash;77 years).Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks (period 1) with prolonged-release melatonin or placebo, followed by a one-week washout period, and then crossed over for another 3 weeks (period 2) of treatment with the other preparation. All tablets were taken 2 hours before bedtime for a period of 3 weeks. In an extension period of 5 months, prolonged-release melatonin was given nightly to all patients in an open-label design. Sleep was objectively monitored in a subgroup of 22 patients using wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, and some antioxidants, as well as glycosylated hemoglobin (HbA1c) levels were measured at baseline and at the end of the study. All concomitant medications were continued throughout the study.Results: No significant changes in serum glucose, fructosamine, insulin, C-peptide, antioxidant levels or blood chemistry were observed after 3 weeks of prolonged-release melatonin treatment. Sleep efficiency, wake time after sleep onset, and number of awakenings improved significantly with prolonged-release melatonin as compared with placebo. Following 5 months of prolonged-release melatonin treatment, mean HbA1c (&plusmn;standard deviation) was significantly lower than at baseline (9.13% &plusmn; 1.55% versus 8.47% &plusmn; 1.67%, respectively, P = 0.005).Conclusion: Short-term use of prolonged-release melatonin improves sleep maintenance in type 2 diabetic patients with insomnia without affecting glucose and lipid metabolism. Long-term prolonged-release melatonin administration has a beneficial effect on HbA1c, suggesting improved glycemic control.Keywords: sleep, insulin, type 2 diabetes, glucose, melatoninGarfinkel DZorin MWainstein JMatas ZLaudon MZisapel NDove Medical PressarticleSpecialties of internal medicineRC581-951ENDiabetes, Metabolic Syndrome and Obesity: Targets and Therapy, Vol 2011, Iss default, Pp 307-313 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Specialties of internal medicine RC581-951
spellingShingle	Specialties of internal medicine RC581-951 Garfinkel D Zorin M Wainstein J Matas Z Laudon M Zisapel N Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
description	Doron Garfinkel1, Mariana Zorin2, Julio Wainstein2, Zipora Matas3, Moshe Laudon4, Nava Zisapel4,51Geriatric Palliative Department, Shoham Geriatric Medical Center, Pardes Hana, Israel; 2Diabetes Unit, 3Biochemistry Laboratory, The E Wolfson Medical Center, Holon, Israel; 4Neurim Pharmaceuticals Ltd, 5Department of Neurobiology, Tel Aviv University, Tel Aviv, IsraelBackground: Diabetes is a major comorbidity in insomnia patients. The efficacy and safety of prolonged-release melatonin 2 mg in the treatment of glucose, lipid metabolism, and sleep was studied in 36 type 2 diabetic patients with insomnia (11 men, 25 women, age 46&ndash;77 years).Methods: In a randomized, double-blind, crossover study, the subjects were treated for 3 weeks (period 1) with prolonged-release melatonin or placebo, followed by a one-week washout period, and then crossed over for another 3 weeks (period 2) of treatment with the other preparation. All tablets were taken 2 hours before bedtime for a period of 3 weeks. In an extension period of 5 months, prolonged-release melatonin was given nightly to all patients in an open-label design. Sleep was objectively monitored in a subgroup of 22 patients using wrist actigraphy. Fasting glucose, fructosamine, insulin, C-peptide, triglycerides, total cholesterol, high-density and low-density lipoprotein cholesterol, and some antioxidants, as well as glycosylated hemoglobin (HbA1c) levels were measured at baseline and at the end of the study. All concomitant medications were continued throughout the study.Results: No significant changes in serum glucose, fructosamine, insulin, C-peptide, antioxidant levels or blood chemistry were observed after 3 weeks of prolonged-release melatonin treatment. Sleep efficiency, wake time after sleep onset, and number of awakenings improved significantly with prolonged-release melatonin as compared with placebo. Following 5 months of prolonged-release melatonin treatment, mean HbA1c (&plusmn;standard deviation) was significantly lower than at baseline (9.13% &plusmn; 1.55% versus 8.47% &plusmn; 1.67%, respectively, P = 0.005).Conclusion: Short-term use of prolonged-release melatonin improves sleep maintenance in type 2 diabetic patients with insomnia without affecting glucose and lipid metabolism. Long-term prolonged-release melatonin administration has a beneficial effect on HbA1c, suggesting improved glycemic control.Keywords: sleep, insulin, type 2 diabetes, glucose, melatonin
format	article
author	Garfinkel D Zorin M Wainstein J Matas Z Laudon M Zisapel N
author_facet	Garfinkel D Zorin M Wainstein J Matas Z Laudon M Zisapel N
author_sort	Garfinkel D
title	Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
title_short	Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
title_full	Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
title_fullStr	Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
title_full_unstemmed	Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
title_sort	efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/d5204dc4b68d4c1cadce845792db1968
work_keys_str_mv	AT garfinkeld efficacyandsafetyofprolongedreleasemelatoninininsomniapatientswithdiabetesarandomizeddoubleblindcrossoverstudy AT zorinm efficacyandsafetyofprolongedreleasemelatoninininsomniapatientswithdiabetesarandomizeddoubleblindcrossoverstudy AT wainsteinj efficacyandsafetyofprolongedreleasemelatoninininsomniapatientswithdiabetesarandomizeddoubleblindcrossoverstudy AT matasz efficacyandsafetyofprolongedreleasemelatoninininsomniapatientswithdiabetesarandomizeddoubleblindcrossoverstudy AT laudonm efficacyandsafetyofprolongedreleasemelatoninininsomniapatientswithdiabetesarandomizeddoubleblindcrossoverstudy AT zisapeln efficacyandsafetyofprolongedreleasemelatoninininsomniapatientswithdiabetesarandomizeddoubleblindcrossoverstudy
_version_	1718399482626834432

Efficacy and safety of prolonged-release melatonin in insomnia patients with diabetes: a randomized, double-blind, crossover study

Ejemplares similares