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IRCT20200301046655N2 IRCT 2023-08-13 Tehran University of Medical Sciences Effect of fasting diet in sleeve surgery Investigation the effect of intermittent fasting diet in comparison with calorie restriction diet on pre-, intra- and postoperative clinical outcomes in patients undergoing sleeve gastrectomy surgery: A clinical trial 2023-07-23 anticipated 60 Complete https://irct.ir/trial/71426 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this trial, the balanced random block method will be used, with a block size of 4 (combination of A and B as groups). Using the Randomization.com website, random allocation will be done for 60 people in the form of 15 blocks of 4. Since body mass index is an important variable in the intervention effect. This intervention will be implemented in a classified manner. In order to properly implement this trial, a random allocation list will be generated separately for each of the two classes of body mass index 40 to 45 and 45 to 50, Blinding description: the principal investigator, the surgeon, the anesthetist, the ward nurses, the person in charge of data collection and the person who evaluates the outcome will not know whether the type of diet received was intermittent fasting or calorie restriction. N/A Sleeve gastrectomy surgery. Intervention 1: Intervention group: Intermittent fasting diet of 16:8 type (16 hours only allowed to receive water, non-energy drinks, tea, coffee and free consumption of food for 8 hours), in case of weakness or headache, it is explained to the participants that they should eat a snack consisting of 200 kilocalories of mixed nuts (18 grams of fat, 5 grams of protein, 4 grams of carbohydrates), in fact a low carbohydrate snack. This diet will be followed for 4 weeks before sleeve gastrectomy surgery. Intervention 2: Control group: The calorie restriction diet (after calculating the amount of calories required by the Mifflin method, in which the actual weight is in kilograms and height in centimeters based on the year, and by applying the coefficient of physical activity and calorific value of food, 25% of the total estimated calories will be reduced and the food plan will be adjusted for each person) will be observed for 4 weeks before the sleeve gastrectomy surgery. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Razieh Khalooeifard
Sina Hospital, Hassan Abad Square, Imam Khomeini St.
Tehran Iran (Islamic Republic of) 11367 46911 +98 21 6634 8500 shkhalooei1367@gmail.com Tehran University of Medical Sciences scientific Razieh Khalooeifard
Sina Hospital, Hassan Abad Square, Imam Khomeini Street
Tehran Iran (Islamic Republic of) 11367 46911 +98 21 6634 8500 shkhalooei1367@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Willingness to participate in the study Body mass index ≥ 40 A candidate for elective sleeve gastrectomy surgery American Society of Anesthesiology classification grade: 1-2 18 years 65 years Both Vegetarians Previous history of bariatric surgery Diabetics treated with insulin People with uncontrolled high blood pressure Z98.84 Bariatric surgery status Prevention Prevention Intervention group: Intermittent fasting diet of 16:8 type (16 hours only allowed to receive water, non-energy drinks, tea, coffee and free consumption of food for 8 hours), in case of weakness or headache, it is explained to the participants that they should eat a snack consisting of 200 kilocalories of mixed nuts (18 grams of fat, 5 grams of protein, 4 grams of carbohydrates), in fact a low carbohydrate snack. This diet will be followed for 4 weeks before sleeve gastrectomy surgery. Control group: The calorie restriction diet (after calculating the amount of calories required by the Mifflin method, in which the actual weight is in kilograms and height in centimeters based on the year, and by applying the coefficient of physical activity and calorific value of food, 25% of the total estimated calories will be reduced and the food plan will be adjusted for each person) will be observed for 4 weeks before the sleeve gastrectomy surgery. Liver size. Timepoint: At the beginning of the study (before the start of the intervention) and before surgery. Method of measurement: sonography. Weight. Timepoint: At the beginning of the study (before the start of the intervention) and before surgery. Method of measurement: scales. Body mass index. Timepoint: At the beginning of the study (before the start of the intervention) and before surgery. Method of measurement: The ratio of weight (in kilograms) to the second power of height in meters. Lipid profile. Timepoint: At the beginning of the study (before the start of the intervention) and before surgery. Method of measurement: blood test. Liver enzymes. Timepoint: At the beginning of the study (before the start of the intervention) and before surgery. Method of measurement: blood test. Duration of anesthesia. Timepoint: From the time of the induction of anesthesia to extubation of the patient. Method of measurement: in minutes and from the patient's medical record. Duration of surgery. Timepoint: The duration of surgery from the time of prep and drape to the completion of suturing. Method of measurement: in minutes and from the patient's medical record. Duration of hospitalization. Timepoint: From the time of admission to the surgical department until discharge. Method of measurement: by day and through the patient's medical record. Tehran University of Medical Sciences Approved 2022-09-28 Research Ethics committee of Sina Hospital Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town Tehran Tehran Iran (Islamic Republic of)