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

Not Applicable

Completed

• Conditions: Epilepsy, Drug Resistant
• Interventions: Other: modified adkins diet; Drug: Pharmacotherapy without diet

• Registration Number: NCT03183076
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Study Start: 2015-09-01
• Primary Completion: 2016-04-30
• Study Completion: 2016-12-30
• Status Verified: 2017-05
• Study First Submitted: 2017-05-31
• Study First Submitted QC: 2017-06-08
• Last Update Submitted: 2017-06-08
• Study First Posted: 2017-06-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modified adkins diet	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.
Pharmacotherapy without diet	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.

Primary Outcome Measures

Name	Time	Method
Frequency of epileptic seizures	3 months	Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Western Medical Center, Mexican Institute of Social Security; 🇲🇽 Guadalajara, Jalisco, Mexico