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IRCT20230917059447N1 IRCT 2023-09-24 Shahid Beheshti University of Medical Sciences Comparison of the effect of intensive lifestyle intervention including two diets, calorie-carbohydrate restricted diet and the time restricted feeding on glycemic biomarkers, eating disorders, and appetite in type 2 diabetes patients Comparison of the effect of intensive lifestyle intervention including two diets, calorie-carbohydrate restricted diet and the time restricted feeding on glycemic biomarkers, eating disorders, and appetite, in overweight and obese type 2 diabetic patients: a randomized controlled trial study 2023-09-23 anticipated 90 Complete https://irct.ir/trial/72666 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The purpose of randomization is to control the effect of all the influencing variables on the results of the study and prevent interference between treatment groups. Randomization will be done in the form of (1:1:1) through the randomized block method, and the sealed envelope method will be used to randomize, so that people will be randomly assigned to one of the three study groups. including providing a carbohydrate-restricted intermittent fasting diet, a continuous calorie-restricted diet with carbohydrate restriction, or receiving care based on guidelines (control). Due to the nature of the intervention under study, participants, intervention providers will be aware of the group allocation. 1-2 Diabetes. Intervention 1: Intervention group: Intermittent fasting group plus calorie restriction and carbohydrate restriction+ Physical activity + Behavior modification. Intervention 2: Intervention group: Calorie and carbohydrate restriction group+ Physical activity+ Behavior modification. Intervention 3: Control group: Control group and standard care. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Parvin mirmiran
Faculty of Nutrition Sciences, Shahid Hafezi StQuds town (West) Farhzadi Blvd, Tehran
Tehran Iran (Islamic Republic of) ۱۹۸۱۶۱۹۵۷۳ +98 21 2235 7483 parvin.mirmiran@gmail.com Shahid Beheshti University of Medical Sciences scientific Sakineh Shab-bidar
Faculty of Nutrition and Dietetics,Tehran University of Medical Sciences: No. 44, Hojat Dost St., Naderi St., Keshavarz Blvd., Tehran
Tehran Iran (Islamic Republic of) 1417935840 +98 21 8895 5975 s_shabbidar@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Men and women 18-65 years old Less than 5 years duration of type 2 diabetes (diagnosis based on 2 tests recorded at the diagnostic level, HbA1c and/or blood glucose) Use of at least one blood glucose-lowering medication HbA1c more than 43 mmol/mol (6.1%) with hypoglycemic drugs Body mass index (BMI) >45 and <27 18 years 65 years Both Use of insulin Use of diabetes drugs from the category of GLP-1 agonists and SGLT-2 inhibitors Recent routine HbA1c ≥ 10% Weight loss of more than 5 kg in the last 6 months Impaired kidney function (eGFR < 60 ml per minute) Uncontrolled blood pressure (more than 160 mm Hg systolic or more than 100 mm Hg diastolic) Diseases including cancer - heart disease - gout - diagnosed eating disorders - patients with confirmed mental disorders Current treatment with Anti-obesity medications History of bariatric surgery Currently pregnant or lactating, or planning to become pregnant in the next 12 months Drug abuse Night shift workers Inability to perform physical activities N/A N/A N/A Intervention group: Intermittent fasting group plus calorie restriction and carbohydrate restriction+ Physical activity + Behavior modification Intervention group: Calorie and carbohydrate restriction group+ Physical activity+ Behavior modification Control group: Control group and standard care Appetite self-report score. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Visual Analogue Scale. Eating Disorder Examination Score. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Eating Disorder Examination Questionnaire (EDEQ). Height. Timepoint: Baseline. Method of measurement: Tape. Weight. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Scale. Body mass index. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Body composition analyzer. Waist circumference. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Tape. Hip circumference. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Tape. Fat mass. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Body composition analyzer. Fat free mass. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Body composition analyzer. Diabetes remission. Timepoint: 3 months and 6 months after the start of the study. Method of measurement: Glycosylated hemoglobin. Total cholesterol. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test. Low-density lipoprotein. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test. High-density lipoprotein. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test. Triglyceride. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test. Emotional distress. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Problem Areas in Diabetes(PAID) Questionnaire. Quality of life. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: The quality-adjusted life year (QALY) Questionnaire. Glycosylated hemoglobin. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test. Fasting blood sugar. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test. Insulin. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test. Insulin resistance index. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Formula. Binge eating score. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Gormally Binge eating questionnaire. Research project of Shahid Beheshti University of Medical Sciences - Institute of Nutritional Research and Food Industries of the country Approved 2023-07-24 Ethics committee of Shahid beheshti University of Medical Sciences 6th Floor, Building No. 2, Central Headquarters of Shahid Beheshti University of Medical Sciences and Health Services, Arabi St., Yaman St., Shahid Chamran Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)