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

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients

Conditions
-----------------
Epilepsy, Drug Resistant

Intervention / Treatment
-----------------
* Other: modified adkins diet
* Drug: Pharmacotherapy without diet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinical trial, Parallel, controled
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: modified adkins diet<br>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. | Other: modified adkins diet<br>* 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<br>* Other names: adkins diet in drug-resistant epilepsy;|
| Active Comparator: Pharmacotherapy without diet<br>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. | Drug: Pharmacotherapy without diet<br>* Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet<br>* Other names: treatment with antiepileptic drugs;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of epileptic seizures | Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapeutic response observed in electroencephalogram | Panic electroencephalographic criteria on the therapeutic response. Having regard to the standardization, improvement or worsening of the crisis in the electroencephalogram | 3 months | 
| Measurement of quality of life and decrease in seizures | 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. | 3 months | 
| Blood tests (Hematic biometry) | Take this blood test to assess the general conditions of the patient and see their levels of hemoglobin, hematocrit, leukocyte and platelet count. | 3 months | 
| Blood chemistry (serum electrolytes) | It will evaluate the general condition of the patient and with this test rule out the presence of electrolyte imbalance | 3 months | 
| liver function tests | 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 | 3 months | 
| ketonuria | It will assess the levels of ketones in urine due to the change in the diet of patients with the Atkins diet | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, Carbohydrate-Restricted, epilepsy, Drug Resistance