Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy
NCT ID: NCT03183076
Last Updated: 2017-06-09
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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COMPLETED
NA
14 participants
INTERVENTIONAL
2015-09-01
2016-12-30
Brief Summary
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Low income earners, many of which do not have a social security, must meet the high costs by Antiepileptic Drugs (AEDS), which in addition should be used in conjunction or combination therapy, because monotherapy is insufficient .
The diet adkins makes some changes in the traditional food habits by others that are accessible and not necessarily expensive, whose mechanism allows for better control of the seizures.
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Detailed Description
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The objective of this work is to analyze the efficacy, tolerability and adherence of the modified atkins diet in adult patients with drug-resistant epilepsy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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modified adkins diet
modified adkins diet. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis.
modified adkins diet
Patients were assigned to two groups, one of them received modified adkins diet for treatment of drug-resistant epilepsy. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis
Pharmacotherapy without diet
It consists in administer only pharmacological treatment withot a special diet, Drug-resistant epilepsy is characterized by the use of antiepileptic drugs and in optimal doses, depending on the type of epilepsy, at least on two consecutive occasions without response to management.
Pharmacotherapy without diet
Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet
Interventions
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modified adkins diet
Patients were assigned to two groups, one of them received modified adkins diet for treatment of drug-resistant epilepsy. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis
Pharmacotherapy without diet
Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients that meet the criteria of drug-resistant epilepsy
* Patients treated with Rational polytherapy, a minimum of 6 months, with no changes in their drug refractory condition.
* Patients with drug- resistant epilepsy with informed consent signed by themselves and their proxy.
* Patients with drug-resistant epilepsy of any etiology, except tumor, metabolic, degenerative or progressive.
Exclusion Criteria
* Patients with a neurological entity progressive and fatal
* Patients with congenital diseases and difficulty to metabolize fats or that require high amounts of carbohydrates in the diet.
18 Years
ALL
No
Sponsors
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Instituto Mexicano del Seguro Social
OTHER_GOV
Responsible Party
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María Ingrid Alanis Guevara
MD neurologist
Principal Investigators
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María I Alanis
Role: PRINCIPAL_INVESTIGATOR
Instituto Mexicano del Seguro Social
Locations
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Western Medical Center, Mexican Institute of Social Security
Guadalajara, Jalisco, Mexico
Countries
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References
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Proposal for revised classification of epilepsies and epileptic syndromes. Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1989 Jul-Aug;30(4):389-99. doi: 10.1111/j.1528-1157.1989.tb05316.x. No abstract available.
Panico LR, Rios VG, Demartini MG, Carniello MA. [The electroencephalographic evolution of a group of patients on a ketonic diet]. Rev Neurol. 2000 Jan 1-15;30(1):8-15. Spanish.
Freeman J, Veggiotti P, Lanzi G, Tagliabue A, Perucca E; Institute of Neurology IRCCS C. Mondino Foundation. The ketogenic diet: from molecular mechanisms to clinical effects. Epilepsy Res. 2006 Feb;68(2):145-80. doi: 10.1016/j.eplepsyres.2005.10.003.
Kossoff EH, Zupec-Kania BA, Amark PE, Ballaban-Gil KR, Christina Bergqvist AG, Blackford R, Buchhalter JR, Caraballo RH, Helen Cross J, Dahlin MG, Donner EJ, Klepper J, Jehle RS, Kim HD, Christiana Liu YM, Nation J, Nordli DR Jr, Pfeifer HH, Rho JM, Stafstrom CE, Thiele EA, Turner Z, Wirrell EC, Wheless JW, Veggiotti P, Vining EP; Charlie Foundation, Practice Committee of the Child Neurology Society; Practice Committee of the Child Neurology Society; International Ketogenic Diet Study Group. Optimal clinical management of children receiving the ketogenic diet: recommendations of the International Ketogenic Diet Study Group. Epilepsia. 2009 Feb;50(2):304-17. doi: 10.1111/j.1528-1167.2008.01765.x. Epub 2008 Sep 23.
Berg AT, Kelly MM. Defining intractability: comparisons among published definitions. Epilepsia. 2006 Feb;47(2):431-6. doi: 10.1111/j.1528-1167.2006.00440.x.
Brodie MJ, Kwan P. Staged approach to epilepsy management. Neurology. 2002 Apr 23;58(8 Suppl 5):S2-8. doi: 10.1212/wnl.58.8_suppl_5.s2.
Kwan P, Arzimanoglou A, Berg AT, Brodie MJ, Allen Hauser W, Mathern G, Moshe SL, Perucca E, Wiebe S, French J. Definition of drug resistant epilepsy: consensus proposal by the ad hoc Task Force of the ILAE Commission on Therapeutic Strategies. Epilepsia. 2010 Jun;51(6):1069-77. doi: 10.1111/j.1528-1167.2009.02397.x. Epub 2009 Nov 3.
Kwan P, Brodie MJ. Definition of refractory epilepsy: defining the indefinable? Lancet Neurol. 2010 Jan;9(1):27-9. doi: 10.1016/S1474-4422(09)70304-7. Epub 2009 Nov 13. No abstract available.
Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
Martinez-Juarez IE, Lopez-Zapata R, Gomez-Arias B, Bravo-Armenta E, Romero-Ocampo L, Estevez-Cruz Z, Hernandez-De la Cruz G, Moran-Molina S. [Refractory epilepsy: use of the new definition and related risk factors. A study in the Mexican population of a third-level centre]. Rev Neurol. 2012 Feb 1;54(3):159-66. Spanish.
Shorvon SD. The epidemiology and treatment of chronic and refractory epilepsy. Epilepsia. 1996;37 Suppl 2:S1-S3. doi: 10.1111/j.1528-1157.1996.tb06027.x.
Devinsky O. Patients with refractory seizures. N Engl J Med. 1999 May 20;340(20):1565-70. doi: 10.1056/NEJM199905203402008. No abstract available.
Arroyo S. [Evaluation of drug-resistant epilepsy]. Rev Neurol. 2000 May 1-15;30(9):881-6. Spanish.
Benbadis SR, Tatum WO, Vale FL. When drugs don't work: an algorithmic approach to medically intractable epilepsy. Neurology. 2000 Dec 26;55(12):1780-4. doi: 10.1212/wnl.55.12.1780. No abstract available.
Hauser WA. The natural history of drug resistant epilepsy: epidemiologic considerations. Epilepsy Res Suppl. 1992;5:25-8.
Marson AG, Appleton R, Baker GA, Chadwick DW, Doughty J, Eaton B, Gamble C, Jacoby A, Shackley P, Smith DF, Tudur-Smith C, Vanoli A, Williamson PR. A randomised controlled trial examining the longer-term outcomes of standard versus new antiepileptic drugs. The SANAD trial. Health Technol Assess. 2007 Oct;11(37):iii-iv, ix-x, 1-134. doi: 10.3310/hta11370.
Sanchez-Alvarez JC, Serrano-Castro P, Canadillas-Hidalgo F. [Refractory epilepsy in adults]. Rev Neurol. 2002 Nov 16-30;35(10):931-53. Spanish.
Serrano Castro PJ, Sanchez Alvarez JC. [Controversies about the new anti-epileptic drugs]. Rev Neurol. 2001 Jan 16-31;32(2):165-71. Spanish.
Gomez-Alonso J, Giraldez BG. [Epilepsy: a new definition for an old disease]. Rev Neurol. 2007 Jul 16-31;45(2):126-7. No abstract available. Spanish.
Fisher RS, van Emde Boas W, Blume W, Elger C, Genton P, Lee P, Engel J Jr. Epileptic seizures and epilepsy: definitions proposed by the International League Against Epilepsy (ILAE) and the International Bureau for Epilepsy (IBE). Epilepsia. 2005 Apr;46(4):470-2. doi: 10.1111/j.0013-9580.2005.66104.x.
Hefft S, Jonas P. Asynchronous GABA release generates long-lasting inhibition at a hippocampal interneuron-principal neuron synapse. Nat Neurosci. 2005 Oct;8(10):1319-28. doi: 10.1038/nn1542. Epub 2005 Sep 11.
Hestrin S, Galarreta M. Synchronous versus asynchronous transmitter release: a tale of two types of inhibitory neurons. Nat Neurosci. 2005 Oct;8(10):1283-4. doi: 10.1038/nn1005-1283. No abstract available.
Callaghan BC, Anand K, Hesdorffer D, Hauser WA, French JA. Likelihood of seizure remission in an adult population with refractory epilepsy. Ann Neurol. 2007 Oct;62(4):382-9. doi: 10.1002/ana.21166.
Duncan JS. The outcome of epilepsy surgery. J Neurol Neurosurg Psychiatry. 2001 Apr;70(4):432. doi: 10.1136/jnnp.70.4.432. No abstract available.
Huttenlocher PR, Wilbourn AJ, Signore JM. Medium-chain triglycerides as a therapy for intractable childhood epilepsy. Neurology. 1971 Nov;21(11):1097-103. doi: 10.1212/wnl.21.11.1097. No abstract available.
Panico LR, Demartini MG, Rios VG, Carniello MA. [The ketogenic diet in infantile refractory epilepsy: electroclinical response, complications and secondary effects]. Rev Neurol. 2000 Aug 1-15;31(3):212-20. Spanish.
Lefevre F, Aronson N. Ketogenic diet for the treatment of refractory epilepsy in children: A systematic review of efficacy. Pediatrics. 2000 Apr;105(4):E46. doi: 10.1542/peds.105.4.e46.
Vicente-Hernandez M, Garcia-Garcia P, Gil-Nagel A, Lopez-Munoz F, Alamo C. [Therapeutic approach to epilepsy from the nutritional view: current status of dietary treatment]. Neurologia. 2007 Oct;22(8):517-25. Spanish.
Yudkoff M, Daikhin Y, Melo TM, Nissim I, Sonnewald U, Nissim I. The ketogenic diet and brain metabolism of amino acids: relationship to the anticonvulsant effect. Annu Rev Nutr. 2007;27:415-30. doi: 10.1146/annurev.nutr.27.061406.093722.
Martin-McGill KJ, Bresnahan R, Levy RG, Cooper PN. Ketogenic diets for drug-resistant epilepsy. Cochrane Database Syst Rev. 2020 Jun 24;6(6):CD001903. doi: 10.1002/14651858.CD001903.pub5.
Other Identifiers
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F2016-1301-72
Identifier Type: -
Identifier Source: org_study_id
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