Clinical trial NCT03183076: Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy
Official title: Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy, Drug Resistant
Keywords: epilepsy
Diet, Carbohydrate-Restricted
Drug Resistance
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2017-06-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical trial, Parallel, controled
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Frequency of epileptic seizures
timeFrame: 3 months
Secondary outcomes:
measure: Therapeutic response observed in electroencephalogram
timeFrame: 3 months
measure: Measurement of quality of life and decrease in seizures
timeFrame: 3 months
measure: Blood tests (Hematic biometry)
timeFrame: 3 months
measure: Blood chemistry (serum electrolytes)
timeFrame: 3 months
measure: liver function tests
timeFrame: 3 months
measure: ketonuria
timeFrame: 3 months
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Western Medical Center, Mexican Institute of Social Security
state: Jalisco
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: María I Alanis
role: PRINCIPAL_INVESTIGATOR
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