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

Investigating 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

The clinical trial has 2 intervention groups and a control group, without blinding, with 30 patients in each group. Randomized with 2 phases, each phase 3 months. Randomization will be done in the form of (1:1:1) through the method of randomized blocks.

Patients from the endocrinology clinic in Tehran. They enter the first phase. Then they enter the maintenance and monitoring phase. Measurements will be done at the beginning, 3 months, and 6 months after the start of the study.

Inclusion criteria: Men and women 18-65 years old Less than 5 years duration of type 2 diabetes Use of at least one blood glucose-lowering medication HbA1c more than 10 percent Body mass index>45and<27 Exclusion criteria: Use of insulin, GLP-1 agonists, and SGLT-2 inhibitors, anti-obesity drugs, Recent routine HbA1c ≥10%, Weight loss of more than 5 kg in the last 6 months, kinds of diseases, Pregnancy or breastfeeding, or planning to become pregnant in the next 12 months, Drug abuse, Inability to perform physical activities

phase1: Group1: Intermittent fasting group+calorie restriction and carbohydrate restriction+physical activity+ Behavior modification Group2:The calorie and carbohydrate restriction+physical activity+Behavior modification Control group: Standard care Phase2: Group1 and2: Weight maintenance diet Group3: Control group and standard care

Glycemic biomarkers (glycosylated hemoglobin, fasting blood sugar, fasting insulin, insulin resistance index) and appetite self-report score using a visual analog scale and eating disorder score

Because this project is a thesis, professors' opinions, and needs assessment in diabetic patients during the implementation of the project, changes were made, including the addition of behavioral intervention and examination of the eating disorder factor in these patients.

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.