The effect of calorie-carbohydrate restricted diet compared to a time restricted feeding combined with calorie-carbohydrate restriction on glycemic and appetite biomarkers in type 2 diabetes patients

Phase 1

Recruiting

Conditions: Diabetes.

Registration Number: IRCT20230917059447N1

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 90

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;Gastric inhibitory peptide. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test.;Glucagon-like peptide-1. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Blood test.;Appetite self-report score. Timepoint: First, 3 months and 6 months after the start of the study. Method of measurement: Visual Analogue Scale.

Secondary Outcome Measures