type 2 diabetes. E11.9 – Type 2 diabetes mellitus without complications
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Body Mass Index (BMI) between 25 kg/m² and less than 35 kg/m² No use of medications that affect appetite, body weight, or have anti-inflammatory properties No participation in any weight loss programs during the past 6 months (i.e., less than 10% weight reduction in the past 6 months) No significant change in physical activity during the past 4 weeks No use of antioxidants, multivitamins, or any type of dietary supplements in the past 3 months
Exclusion criteria
Exclusion criteria: Pregnancy or lactation History of gastrointestinal or bariatric surgery Liver dysfunction History of alcohol or other substance abuse History of endocrine disorders (especially hypothyroidism)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| "Leptin and adiponectin hormone levels – measuring changes in the quality of life of patients with type 2 diabetes using validated scales such as the Diabetes Quality of Life Scale.". Timepoint: "At baseline and at the end of the study (2 months later)". Method of measurement: "Serum levels of leptin and adiponectin will be measured using ELISA kits at baseline and two months after the intervention. Quality of life will be assessed using the standardized Diabetes Quality of Life Questionnaire at the beginning and end of the study.". | — |
Secondary
| Measure | Time frame |
|---|---|
| Scores of depression, anxiety, and stress based on the DASS-21 questionnaire. Timepoint: "At baseline and at the end of the study (2 months later)". Method of measurement: The 21-item Depression, Anxiety, and Stress Questionnaire will be used to assess the psychological status of participants at baseline and at the end of the 2-month intervention. This instrument consists of three separate subscales: depression, anxiety, and stress. | — |
Countries
Iran (Islamic Republic of)
Contacts
Shiraz University of Medical Sciences