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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

Protocol summary

Summary
This study aimed to investigate the effect of smaller amounts of weight loss in different ways (surgery and diet plus exercise) on intensity, duration and frequency of migraine headaches in obese patients. Of people with migraine and overweight or obese referred to Sina hospital (Hasan Abad Avenue, TUMS, Tehran, Iran) weight loss clinic, 54 patients will be included in this clinical trial study. The characteristics of headache in 54 patients (27 in each of the bariateric surgery group or diet therapy and exercise group) with migraine and morbid obesity (BMI 35 to 93.9 range with co-morbidities or BMI> =40) for 4 weeks before surgery and at the end of the first, and sixth month of the intervention will be examined by trained physicians. In addition, a headache diary form will be fulfilled by the subjects for 4 weeks prospectively. Also, details of diet and exercise after surgery will be obtained using 3 days dietary recall and International Physical Activity Questionnaires (IPAQ) at baseline and at the end of the first and sixth months after beginning the intervention. The treatment procedure will be started after 4 weeks of baseline examination. Inclusion criteria for patients in the study were as follows 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). The exclusion criteria were as follows: lack of adherence to diet and exercise to more than 70%; pregnancy; unwillingness to cooperate in the study. The main objectives of this trial: the effect of weight loss through bariatric surgery on severity of migraine headache(using VAS), frequency and duration of migraine at one, and six months after the intervention. The effect of weight loss through diet therapy and exercise on severity of migraine headache(using VAS), frequency and duration of migraine at one, and six months after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201612069157N2
Registration date: 2016-12-26, 1395/10/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-12-26, 1395/10/06
Registrant information
Name
Prof Mansoureh Togha
Name of organization / entity
Neurology department, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 2052
Email address
toghae@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Neuroscience research center, Imam Khomeini Hospital Keshavarz Boulevard, Tehran University of Medical Sciences, Tehran, Iran
Expected recruitment start date
2016-05-02, 1395/02/13
Expected recruitment end date
2016-10-23, 1395/08/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
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
Purpose
Prevention
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehra University of Medical Sciences
Street address
Tehra University of Medical Sciences, Qhods St., Keshavarz Boulevard
City
Tehran
Postal code
Approval date
2016-05-01, 1395/02/12
Ethics committee reference number
IR.TUMS.REC.1395.2511

Health conditions studied

1

Description of health condition studied
Migraine headache
ICD-10 code
G43.9
ICD-10 code description
Migraine, unspecified

Primary outcomes

1

Description
Migraine severity
Timepoint
Baseline, one month and 6 months after the intervention
Method of measurement
Visual Analog Scale (VAS)

2

Description
Migraine headache duration
Timepoint
Baseline, one month and 6 months after the intervention
Method of measurement
Migraine headache diary

3

Description
Migraine headache frequency
Timepoint
Baseline, one month and 6 months after the intervention
Method of measurement
Migraine headache diary

Secondary outcomes

1

Description
Amount of weight reduction
Timepoint
Baseline, 1 and 6 months after the intervention
Method of measurement
Weight scale

2

Description
Body fat percentage
Timepoint
Baseline, 1 and 6 months after the intervention
Method of measurement
BIA

Intervention groups

1

Description
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 .
Category
Treatment - Surgery

2

Description
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.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital, weight loss clinic
Full name of responsible person
Dr Soodeh Razeghi Jahromi
Street address
Sina hospital, Hasan bad Sq, Imam Khomeini Ave,Tehran Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iranian Center of Neurological Research, Tehran University of Medical Sciences,
Full name of responsible person
Mrs Zohreh Heidari
Street address
Sixth floor, Central Building of Tehran University of Medical Sciences, Qods Ave., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iranian Center of Neurological Research, Tehran University of Medical Sciences,
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iranian Center of Neurological Research, Tehran University of Medical Sciences
Full name of responsible person
Prof. Mansoureh Togha
Position
Neurologist
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Postal code
1136746911
Phone
+98 21 6670 2052
Fax
+98 21 6634 8553
Email
toghae@sina.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iranian Center of Neurological Research,Tehran University of Medical Sciences
Full name of responsible person
Prof. Mansoureh Togha
Position
Neurologist
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Postal code
1136746911
Phone
+98 21 6670 2052
Fax
+98 21 6634 8553
Email
toghae@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian Center of Neurological Research,Tehran University of Medical Sciences
Full name of responsible person
Prof Mansoureh Togha
Position
Professor
Other areas of specialty/work
Street address
Sina Hospital, Hasan Abad Sq., Imam Khomeini Ave.
City
Tehran
Postal code
1136746911
Phone
+98 21 6670 2052
Fax
+98 21 6634 8553
Email
toghae@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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