NCT06959043 Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
| NCT ID | NCT06959043 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Maria Elizabeth Rossi da Silva |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-11-22 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-11-22 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 disorders (hypothyroidism, hypogonadism, and adrenal insufficiency); * Have eating disorders or have undergone bariatric surgery.
Contact & Investigator
Maria E. R. Silva, MD, PhD
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT06959043 clinical trial?
This trial is open to participants of all sexes, aged 45 Years or older, up to 70 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06959043 currently recruiting?
Yes, NCT06959043 is actively recruiting participants. Contact the research team at mbeth@usp.br for enrollment information.
Where is the NCT06959043 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT06959043 clinical trial?
NCT06959043 is sponsored by Maria Elizabeth Rossi da Silva. The principal investigator is Maria E. R. Silva, MD, PhD at University of Sao Paulo. The trial plans to enroll 60 participants.
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