Effect of Melatonin and Metformin on Glycemic Control Genotoxicity and Cytotoxicity Markers in Patients With Prediabetes
NCT ID: NCT03848533
Last Updated: 2019-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
42 participants
INTERVENTIONAL
2019-08-22
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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melatonin plus metformin
It will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days.
Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before bedtime) per 90 days.
melatonin
The administration of melatonin will be indicated at night before bedtime to avoid alterations of the circadian cycle. It will be contained in bottles labeled "Medication 2" to maintain the masking. This intervention will be indicated in two groups (Melatonin plus metformin and Melatonin plus placebo)
metformin
For the intervention with metformin, prolonged-release tablets will be used to reduce adverse effects and improve adherence to treatment. It will be contained in bottles labeled "Medication 1" to maintain masking. This intervention will be indicated in two groups (Melatonin plus metformin and metformin plus placebo)
metformin plus placebo
It will be indicate metformin 850 mg tablets, once a day in the morning (before breakfast) per 90 days.
Will administrate homologated placebo once a day in the night (before bedtime) per 90 days.
metformin
For the intervention with metformin, prolonged-release tablets will be used to reduce adverse effects and improve adherence to treatment. It will be contained in bottles labeled "Medication 1" to maintain masking. This intervention will be indicated in two groups (Melatonin plus metformin and metformin plus placebo)
Placebo
The placebo may be contained in bottles labeled "Medication 1" or "Medication 2" depending on the time of administration, and the group in which it is used. Placebo will be used in two groups (Melatonin plus placebo and Metformin plus placebo)
melatonin plus placebo
It will be indicate homologated placebo once a day in the morning (before breakfast) per 90 days.
Will administrate melatonin 5 mg lengthed release capsules, once a day in the night (before sleep) per 90 days.
melatonin
The administration of melatonin will be indicated at night before bedtime to avoid alterations of the circadian cycle. It will be contained in bottles labeled "Medication 2" to maintain the masking. This intervention will be indicated in two groups (Melatonin plus metformin and Melatonin plus placebo)
Placebo
The placebo may be contained in bottles labeled "Medication 1" or "Medication 2" depending on the time of administration, and the group in which it is used. Placebo will be used in two groups (Melatonin plus placebo and Metformin plus placebo)
Interventions
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melatonin
The administration of melatonin will be indicated at night before bedtime to avoid alterations of the circadian cycle. It will be contained in bottles labeled "Medication 2" to maintain the masking. This intervention will be indicated in two groups (Melatonin plus metformin and Melatonin plus placebo)
metformin
For the intervention with metformin, prolonged-release tablets will be used to reduce adverse effects and improve adherence to treatment. It will be contained in bottles labeled "Medication 1" to maintain masking. This intervention will be indicated in two groups (Melatonin plus metformin and metformin plus placebo)
Placebo
The placebo may be contained in bottles labeled "Medication 1" or "Medication 2" depending on the time of administration, and the group in which it is used. Placebo will be used in two groups (Melatonin plus placebo and Metformin plus placebo)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Prediabetes state according to the American Diabetes Association criteria.
* Without pharmacological treatment.
* Body mass index between 25 to 34.9 Kg/m2
* Sign informed consent
Exclusion Criteria
* Pregnant woman
* Patients with autoimmune, cancer, reumatic diases history or with pharmaceutical treatment
* Workers on night or changing shifts.
* Subjects that have been exposed to radiation
* Dyslipidemia: Total cholesterol \>250mg/dL, Triglycerides \>500 mg/dL.
* Subjects that have travel to other place with a different time zone.
* Patients with diagnosis of insomnia
* Patients with a glomerular filtration \<60 ml/min using the Cockroft-Gault Formula.
30 Years
60 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Responsible Party
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Lizet Yadira Rosales Rivera
Profesor investigador asociado C
Principal Investigators
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Lizet Yadira Rosales-Rivera, PhD Science
Role: PRINCIPAL_INVESTIGATOR
Instituto de terapeutica experimental y clínica
Locations
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Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Facility Contacts
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Lizet Yadira Rosales-Rivera, PhD Science
Role: primary
References
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American Diabetes Association. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2018. Diabetes Care. 2018 Jan;41(Suppl 1):S13-S27. doi: 10.2337/dc18-S002.
Brannick B, Wynn A, Dagogo-Jack S. Prediabetes as a toxic environment for the initiation of microvascular and macrovascular complications. Exp Biol Med (Maywood). 2016 Jun;241(12):1323-31. doi: 10.1177/1535370216654227.
Ferrannini E, Gastaldelli A, Iozzo P. Pathophysiology of prediabetes. Med Clin North Am. 2011 Mar;95(2):327-39, vii-viii. doi: 10.1016/j.mcna.2010.11.005.
Wilson ML. Prediabetes: Beyond the Borderline. Nurs Clin North Am. 2017 Dec;52(4):665-677. doi: 10.1016/j.cnur.2017.07.011. Epub 2017 Oct 5.
Hostalek U, Gwilt M, Hildemann S. Therapeutic Use of Metformin in Prediabetes and Diabetes Prevention. Drugs. 2015 Jul;75(10):1071-94. doi: 10.1007/s40265-015-0416-8.
Serrano R, Garcia-Soidan FJ, Diaz-Redondo A, Artola S, Franch J, Diez J, Carrillo L, Ezkurra P, Millaruelo JM, Segui M, Sangros FJ, Martinez-Candela J, Munoz P, Goday A, Regidor E; Grupo de Estudio PREDADS. Cohort Study in Primary Health Care on the Evolution of Patients with Prediabetes (PREDAPS): basis and methodology. Rev Esp Salud Publica. 2013 Mar-Apr;87(2):121-35. doi: 10.4321/S1135-57272013000200003. English, Spanish.
Yang H, Jin X, Kei Lam CW, Yan SK. Oxidative stress and diabetes mellitus. Clin Chem Lab Med. 2011 Nov;49(11):1773-82. doi: 10.1515/CCLM.2011.250. Epub 2011 Aug 3.
Giacco F, Brownlee M. Oxidative stress and diabetic complications. Circ Res. 2010 Oct 29;107(9):1058-70. doi: 10.1161/CIRCRESAHA.110.223545.
Tang WH, Martin KA, Hwa J. Aldose reductase, oxidative stress, and diabetic mellitus. Front Pharmacol. 2012 May 9;3:87. doi: 10.3389/fphar.2012.00087. eCollection 2012.
Rolo AP, Palmeira CM. Diabetes and mitochondrial function: role of hyperglycemia and oxidative stress. Toxicol Appl Pharmacol. 2006 Apr 15;212(2):167-78. doi: 10.1016/j.taap.2006.01.003. Epub 2006 Feb 20.
Brownlee M. Biochemistry and molecular cell biology of diabetic complications. Nature. 2001 Dec 13;414(6865):813-20. doi: 10.1038/414813a.
Torres-Bugarin O, Zavala-Cerna MG, Nava A, Flores-Garcia A, Ramos-Ibarra ML. Potential uses, limitations, and basic procedures of micronuclei and nuclear abnormalities in buccal cells. Dis Markers. 2014;2014:956835. doi: 10.1155/2014/956835. Epub 2014 Feb 4.
Jdey W, Thierry S, Popova T, Stern MH, Dutreix M. Micronuclei Frequency in Tumors Is a Predictive Biomarker for Genetic Instability and Sensitivity to the DNA Repair Inhibitor AsiDNA. Cancer Res. 2017 Aug 15;77(16):4207-4216. doi: 10.1158/0008-5472.CAN-16-2693. Epub 2017 Jun 6.
Kisurina-Evgenieva OP, Sutiagina OI, Onishchenko GE. Biogenesis of Micronuclei. Biochemistry (Mosc). 2016 May;81(5):453-64. doi: 10.1134/S0006297916050035.
Graham GG, Punt J, Arora M, Day RO, Doogue MP, Duong JK, Furlong TJ, Greenfield JR, Greenup LC, Kirkpatrick CM, Ray JE, Timmins P, Williams KM. Clinical pharmacokinetics of metformin. Clin Pharmacokinet. 2011 Feb;50(2):81-98. doi: 10.2165/11534750-000000000-00000.
Gong L, Goswami S, Giacomini KM, Altman RB, Klein TE. Metformin pathways: pharmacokinetics and pharmacodynamics. Pharmacogenet Genomics. 2012 Nov;22(11):820-7. doi: 10.1097/FPC.0b013e3283559b22. No abstract available.
Vecchio S, Giampreti A, Petrolini VM, Lonati D, Protti A, Papa P, Rognoni C, Valli A, Rocchi L, Rolandi L, Manzo L, Locatelli CA. Metformin accumulation: lactic acidosis and high plasmatic metformin levels in a retrospective case series of 66 patients on chronic therapy. Clin Toxicol (Phila). 2014 Feb;52(2):129-35. doi: 10.3109/15563650.2013.860985. Epub 2013 Nov 28.
Lalau JD. Lactic acidosis induced by metformin: incidence, management and prevention. Drug Saf. 2010 Sep 1;33(9):727-40. doi: 10.2165/11536790-000000000-00000.
Dunn CJ, Peters DH. Metformin. A review of its pharmacological properties and therapeutic use in non-insulin-dependent diabetes mellitus. Drugs. 1995 May;49(5):721-49. doi: 10.2165/00003495-199549050-00007.
Lardone PJ, Alvarez-Sanchez SN, Guerrero JM, Carrillo-Vico A. Melatonin and glucose metabolism: clinical relevance. Curr Pharm Des. 2014;20(30):4841-53. doi: 10.2174/1381612819666131119101032.
Brzezinski A. Melatonin in humans. N Engl J Med. 1997 Jan 16;336(3):186-95. doi: 10.1056/NEJM199701163360306. No abstract available.
Al-Omary FA. Melatonin: comprehensive profile. Profiles Drug Subst Excip Relat Methodol. 2013;38:159-226. doi: 10.1016/B978-0-12-407691-4.00005-8.
Singh M, Jadhav HR. Melatonin: functions and ligands. Drug Discov Today. 2014 Sep;19(9):1410-8. doi: 10.1016/j.drudis.2014.04.014. Epub 2014 Apr 30.
Hussain SA, Khadim HM, Khalaf BH, Ismail SH, Hussein KI, Sahib AS. Effects of melatonin and zinc on glycemic control in type 2 diabetic patients poorly controlled with metformin. Saudi Med J. 2006 Oct;27(10):1483-8.
Gamboa ML, Canales-Gómez JS, Castro Sandoval T de J. Bioavailability of Long Acting Capsules of Melatonin in Mexican Healthy Volunteers. J Bioequiv Availab. 2010 Sep 30;02(05).
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. Diabetes Metab Syndr Obes. 2011;4:307-13. doi: 10.2147/DMSO.S23904. Epub 2011 Aug 2.
McMullan CJ, Schernhammer ES, Rimm EB, Hu FB, Forman JP. Melatonin secretion and the incidence of type 2 diabetes. JAMA. 2013 Apr 3;309(13):1388-96. doi: 10.1001/jama.2013.2710.
Thomas AP, Hoang J, Vongbunyong K, Nguyen A, Rakshit K, Matveyenko AV. Administration of Melatonin and Metformin Prevents Deleterious Effects of Circadian Disruption and Obesity in Male Rats. Endocrinology. 2016 Dec;157(12):4720-4731. doi: 10.1210/en.2016-1309. Epub 2016 Sep 21.
Reutrakul S, Sumritsopak R, Saetung S, Chanprasertyothin S, Chailurkit LO, Anothaisintawee T. Lower nocturnal urinary 6-sulfatoxymelatonin is associated with more severe insulin resistance in patients with prediabetes. Neurobiol Sleep Circadian Rhythms. 2017 Jun 28;4:10-16. doi: 10.1016/j.nbscr.2017.06.001. eCollection 2018 Jan.
Park JH, Shim HM, Na AY, Bae KC, Bae JH, Im SS, Cho HC, Song DK. Melatonin prevents pancreatic beta-cell loss due to glucotoxicity: the relationship between oxidative stress and endoplasmic reticulum stress. J Pineal Res. 2014 Mar;56(2):143-53. doi: 10.1111/jpi.12106. Epub 2013 Nov 25.
Rybka J, Kedziora-Kornatowska K, Kupczyk D, Muszalik M, Kornatowski M, Kedziora J. Antioxidant effect of immediate- versus sustained-release melatonin in type 2 diabetes mellitus and healthy controls. Drug Deliv. 2016;23(3):814-7. doi: 10.3109/10717544.2014.917343. Epub 2014 May 28.
Lo CC, Lin SH, Chang JS, Chien YW. Effects of Melatonin on Glucose Homeostasis, Antioxidant Ability, and Adipokine Secretion in ICR Mice with NA/STZ-Induced Hyperglycemia. Nutrients. 2017 Oct 29;9(11):1187. doi: 10.3390/nu9111187.
Onaran I, Guven GS, Ozdas SB, Kanigur G, Vehid S. Metformin does not prevent DNA damage in lymphocytes despite its antioxidant properties against cumene hydroperoxide-induced oxidative stress. Mutat Res. 2006 Dec 10;611(1-2):1-8. doi: 10.1016/j.mrgentox.2006.06.036. Epub 2006 Sep 26.
Skrha J, Prazny M, Hilgertova J, Kvasnicka J, Kalousova M, Zima T. Oxidative stress and endothelium influenced by metformin in type 2 diabetes mellitus. Eur J Clin Pharmacol. 2007 Dec;63(12):1107-14. doi: 10.1007/s00228-007-0378-1. Epub 2007 Sep 15.
AIDS networking in Canada, US. CMAJ. 1995 Dec 15;153(12):1772. No abstract available.
Other Identifiers
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CT-MEL-LESM
Identifier Type: -
Identifier Source: org_study_id
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