NCT06959043Recruiting
Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Source: ClinicalTrials.gov · Last updated 18 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 9 Mar 2025
- Start date
- 22 Nov 2022
- Primary completion date
- Aug 2025
- Lead sponsor
- Maria Elizabeth Rossi da Silva
- Diseases
- Type 2 diabetes
- NCT number
- NCT06959043
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 22 Nov 2022 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Be using insulin, anti-obesity medications, antibiotics, and/or probiotic supplements in the 2 months preceding data collection;
- Have limited mobility and a previous diagnosis of cardiopulmonary diseases;
- Report current or previous (within the past two months) diarrhea during screening;
Other illness
- Have liver or kidney failure and uncontrolled endocrine disorders (hypothyroidism, hypogonadism, and adrenal insufficiency);
- Have eating disorders or have undergone bariatric surgery.
Other
- Use of alcohol or tobacco;
Who the study is looking for
- 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.
Age in the registry: 45 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universidade de São Paulo (USP) Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.