Efficacy, Tolerability and Adherence of the Modified Atkins Diet on Drug-resistant Epilepsy in Adults Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Frequency of epileptic seizures
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
MD María Ingrid Alanis Guevara. Neurologist Hospital of the Western National Medical Center. Guadalajara. Mexico
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: modified adkins diet (Other)
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.
干预措施: Pharmacotherapy without diet (Drug)
结局指标
主要结局
Frequency of epileptic seizures
时间窗: 3 months
Frequency of epileptic seizures measured according to the clinical criteria of therapeutic evaluation of Huttenlocher
次要结局
- ketonuria(3 months)
- liver function tests(3 months)
- Therapeutic response observed in electroencephalogram(3 months)
- Measurement of quality of life and decrease in seizures(3 months)
- Blood tests (Hematic biometry)(3 months)
- Blood chemistry (serum electrolytes)(3 months)
研究者
María Ingrid Alanis Guevara
MD neurologist
Instituto Mexicano del Seguro Social