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IRCT201612069157N2 IRCT 2016-12-26 Iranian Center of Neurological Research, Tehran University of Medical Sciences, The effect of weight loss (bariatric surgery or diet therapy with exercise) on migraine charchteristics in obese patients with migraine headaches who referred to Sina hospital weight loss clinic A study of migraine improvement after diet/exercise-induced weight loss or bariatric surgery in patients with chronic migraine who presents to Sina hospital weight-loss clinic 2016-05-02 anticipated 54 Complete https://irct.ir/trial/9761 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention. N/A Migraine headache. Intervention 1: Bariatric Surgery This trial will be conducted on morbid obese patients referred to Sina hospital weight loss clinic after obtaining a written consent. According to the guidelines in the treatment of obesity, bariatric surgery as a treatment is recommended in patients with morbid obesity (a body mass index of 35 to 39.9 with comorbidities or BMI> =40) . Routinely, the morbid obese patients in our obesity clinic are refereed to a laparoscopic surgeon after examining their diet, physical activity and other measures as well as their willingness for bariatric surgery. headache charcteristics including severity (which is obtained using VAS), frequency and duration will be determined at baseline and during the study. Also to assess dietary habits and physical activity levels of patients before surgery, three days of 24 hour dietary recall and IPAQ will be used. After surgery, low-energy diet (600-800 kcal) with 70 grams of protein and 1.8 liters of fluid per day is recommended. The dietary prescriptions for morbid obese patients who underwent surgery will be as follows: For the first day or so after surgery,and second day after the surgery: clear liquid diet, from the third day by the end of the second week: concentrated liquid, mashed and semi-solid in the third and fourth week: semi-solid diet from the end of the fourth week onward solid diet will be prescribed to patients. exercise recommendations will be given to all patients who are undergoing surgery . Intervention 2: Diet therapy and exerciseobese patients who suffered from migraine and having a BMI level between 35 to 39.9 as well as morbid obese patients who are not willing to undergo for the surgery, will be treated with diet therapy and exercise. These individuals will receive 6 months of dietary prescription with exercise recommendations.diet therapy will be started by subtracting 500 to 1000 kcal from the current energy intakes of the patient (50-55% from carbohydrates, 15-20% from protein, 30-35% from fat). The goal is achieving 30 minutes of moderate intensity physical activity per day. for achieving this goal, the patient will be asked to have a regular moderate-intensity aerobic activity for 10 minutes a day and gradually increase it to 30 minutes per day.
public Prof. Mansoureh Togha
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6670 2052 toghae@sina.tums.ac.ir Iranian Center of Neurological Research, Tehran University of Medical Sciences scientific Prof. Mansoureh Togha
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6670 2052 toghae@sina.tums.ac.ir Iranian Center of Neurological Research,Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: having more than 15 headache days per month for at least 3 months; avoiding the use of migraine prophylactic drugs in the last 4 weeks; lack of advanced disease including kidney, heart and liver disease; the absence of major depression and psychotic disorders suffering from morbid obesity (BMI 35 range to 39/9 with co-morbidities or BMI> =40). Exclusion criteria: lack of adherence to diet and exercise to more than 70%; taking Migraine prophylactic drugs; suffering from chronic kidney disease, heart and liver diseases, major depression and psychosis; pregnancy and unwillingness to cooperate in the study. 18 years 65 years Female G43.9 Migraine, unspecified Treatment - Surgery Lifestyle Bariatric Surgery This trial will be conducted on morbid obese patients referred to Sina hospital weight loss clinic after obtaining a written consent. According to the guidelines in the treatment of obesity, bariatric surgery as a treatment is recommended in patients with morbid obesity (a body mass index of 35 to 39.9 with comorbidities or BMI> =40) . Routinely, the morbid obese patients in our obesity clinic are refereed to a laparoscopic surgeon after examining their diet, physical activity and other measures as well as their willingness for bariatric surgery. headache charcteristics including severity (which is obtained using VAS), frequency and duration will be determined at baseline and during the study. Also to assess dietary habits and physical activity levels of patients before surgery, three days of 24 hour dietary recall and IPAQ will be used. After surgery, low-energy diet (600-800 kcal) with 70 grams of protein and 1.8 liters of fluid per day is recommended. The dietary prescriptions for morbid obese patients who underwent surgery will be as follows: For the first day or so after surgery,and second day after the surgery: clear liquid diet, from the third day by the end of the second week: concentrated liquid, mashed and semi-solid in the third and fourth week: semi-solid diet from the end of the fourth week onward solid diet will be prescribed to patients. exercise recommendations will be given to all patients who are undergoing surgery . Diet therapy and exerciseobese patients who suffered from migraine and having a BMI level between 35 to 39.9 as well as morbid obese patients who are not willing to undergo for the surgery, will be treated with diet therapy and exercise. These individuals will receive 6 months of dietary prescription with exercise recommendations.diet therapy will be started by subtracting 500 to 1000 kcal from the current energy intakes of the patient (50-55% from carbohydrates, 15-20% from protein, 30-35% from fat). The goal is achieving 30 minutes of moderate intensity physical activity per day. for achieving this goal, the patient will be asked to have a regular moderate-intensity aerobic activity for 10 minutes a day and gradually increase it to 30 minutes per day. Migraine severity. Timepoint: Baseline, one month and 6 months after the intervention. Method of measurement: Visual Analog Scale (VAS). Migraine headache duration. Timepoint: Baseline, one month and 6 months after the intervention. Method of measurement: Migraine headache diary. Migraine headache frequency. Timepoint: Baseline, one month and 6 months after the intervention. Method of measurement: Migraine headache diary. Amount of weight reduction. Timepoint: Baseline, 1 and 6 months after the intervention. Method of measurement: Weight scale. Body fat percentage. Timepoint: Baseline, 1 and 6 months after the intervention. Method of measurement: BIA. Iranian Center of Neurological Research, Tehran University of Medical Sciences, Approved 2016-05-01 Tehra University of Medical Sciences Tehra University of Medical Sciences, Qhods St., Keshavarz Boulevard Tehran Iran (Islamic Republic of)