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Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise

RecruitingNAAges 45 Years - 70 YearsAllMaria Elizabeth Rossi da Silva
NCT06959043 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Probiotic Supplementation
  • Placebo Administration
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Where

1 site
Universidade de São Paulo (USP)
São Paulo, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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