Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet an
The study evaluates the impact of a strict vegetarian diet combined with regular physical exercise and the use of probiotics on metabolic, inflammatory, and epigenetic parameters in patients with type 2 diabetes. It aims to determine the influence of these interventions on gut microbiota, glycemic control, body composi
| Condition(s) | Type 2 Diabetes Mellitus (T2DM), Insulin Resistance, Inflamation, Gut Microbiomes |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The study evaluates the impact of a strict vegetarian diet combined with regular physical exercise and the use of probiotics on metabolic, inflammatory, and epigenetic parameters in patients with type 2 diabetes. It aims to determine the influence of these interventions on gut microbiota, glycemic control, body composition, insulin resistance, and quality of life. |
| Who can participate | Inclusion Criteria: * Have a medical diagnosis of type 2 diabetes for a maximum of 5 years. * Be omnivorous; Have a Body Mass Index (BMI) ≥ 25 kg/m2 and \< 40 kg/m2; * Be between the ages of 45 and 70, both genders. * Women should be in the postmenopausal stage; * Use no more than three hypoglycemic medications in total; * Have the availability for a four-week consecutive hospitalization at CSVN. Exclusion Criteria: * Be using insulin, anti-obesity medications, antibiotics, and/or probiotic supplements in the 2 months preceding data collection; * Use of alcohol or tobacco; * Have limited mobility and a previous diagnosis of cardiopulmonary diseases; * Report current or previous (within the past two months) diarrhea during screening; * Have liver or kidney failure and uncontrolled endocrine |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Lead sponsor | Maria Elizabeth Rossi da Silva |
| Locations | São Paulo, São Paulo, Brazil |
| Start date | 2022-11-22 |
| NCT ID | NCT06959043 |
| Official listing | https://clinicaltrials.gov/study/NCT06959043 |