Diabetes.
Conditions
Interventions
Intervention 1: Intervention group: Intermittent fasting group plus calorie restriction and carbohydrate restriction+ Physical activity + Behavior modification. Intervention 2: Intervention group: Cal
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 measu | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactParvin mirmiran
Shahid Beheshti University of Medical Sciences
Outcome results
None listed