Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy

NCT03183076 — Not applicable, Completed, 14 participants, Instituto Mexicano del Seguro Social
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Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients

RegistryNCT03183076
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, supportive care
Enrollment14 (Actual)
SponsorInstituto Mexicano del Seguro Social (Other gov)
ConditionsEpilepsy, Drug Resistant
Interventionsmodified adkins diet, Pharmacotherapy without diet (Other, drug)
Datesstart 2015-09-01, primary completion 2016-04-30, completion 2016-12-30, first posted 2017-06-09, last updated 2017-06-09
Locations1 site in Mexico

Related Papers Related Patents Related Grants Related Experts
All trials for Epilepsy, Drug Resistant All trials of modified adkins diet All trials of Pharmacotherapy without diet

-Summary

The Atkins Diet Modified (ADM) is the best alternative treatment for drug-resistant epilepsy, There is a high prevalence worldwide , especially in Latin American countries, including Mexico.

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

Objective: To assess the efficacy, tolerability and adherence of the modified adkins diet in adult patients with drug-resistent epilepsy Materials and Methods: Clinical trial, made up of patients with drug-resistent epilepsy, selected by convenience, who will be handled pharmacologically with the standard treatment of this condition for a period of not less than 6 months, after which they will be treated with adkins diet modified, prior informed consent, to establish its effect and a comparative analysis later.

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.

+Arms and interventions

ArmTypeInterventionsDescription
modified adkins dietActive comparatorOther: modified adkins dietmodified 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.
Pharmacotherapy without dietActive comparatorDrug: Pharmacotherapy without dietIt 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.
  • modified adkins diet (Other), also known as adkins diet in drug-resistant epilepsy: 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 (Drug), also known as treatment with antiepileptic drugs: Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet

+Outcome measures

Primary outcomes

  • Frequency of epileptic seizures [3 months]: Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher

Secondary outcomes

  • Therapeutic response observed in electroencephalogram [3 months]: Panic electroencephalographic criteria on the therapeutic response. Having regard to the standardization, improvement or worsening of the crisis in the electroencephalogram
  • Measurement of quality of life and decrease in seizures [3 months]: Interrogate the patient with a questionnaire of refractory epilepsy drugs. And ask to the patient with this questionnaire if improved their quality of life and have decreased seizures after using the atkins diet modified.
  • Blood tests (Hematic biometry) [3 months]: Take this blood test to assess the general conditions of the patient and see their levels of hemoglobin, hematocrit, leukocyte and platelet count.
  • Blood chemistry (serum electrolytes) [3 months]: It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance
  • liver function tests [3 months]: Will be evaluated with this test levels of transaminases as can be raised by treatment anticonvulsant and see if there are any changes with the changes in the diet of patients
  • ketonuria [3 months]: It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Minimum age of 18 years
* 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 drug-resistant epilepsy simultaneous alternate treatment to the Atkins Diet modified.
* 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.

+Locations (1)

FacilityCityCountryStatus
Western Medical Center, Mexican Institute of Social SecurityGuadalajara, JaliscoMexico

+Publications

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  • 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. PMID 16523530
  • 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. PMID 18823325
  • Results publication: 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. PMID 16499772
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  • Results publication: 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. PMID 19889013
  • Results publication: 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. PMID 19914135
  • Results publication: Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503. PMID 10660394
  • Results publication: 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. PMID 22278892
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  • Results publication: Hauser WA. The natural history of drug resistant epilepsy: epidemiologic considerations. Epilepsy Res Suppl. 1992;5:25-8. PMID 1418457
  • Results publication: 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. PMID 17903391
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  • Results publication: 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. PMID 16189532
  • Results publication: 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. PMID 17880009
  • Results publication: 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. PMID 11254763
  • Results publication: 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. PMID 5166216
  • Results publication: 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. PMID 10996924
  • Results publication: 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. PMID 10742367
  • Results publication: 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. PMID 17641989
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  • Results publication: 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. PMID 32588435

+Investigators

  • María I Alanis, Principal investigator, Instituto Mexicano del Seguro Social