Actively Recruiting
Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Led by Maria Elizabeth Rossi da Silva · Updated on 2025-05-18
60
Participants Needed
1
Research Sites
210 weeks
Total Duration
On this page
Sponsors
M
Maria Elizabeth Rossi da Silva
Lead Sponsor
C
Clínica e Spa Vida Natural
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a medical diagnosis of type 2 diabetes for a maximum of 5 years.
- Be omnivorous.
- Have a Body Mass Index (BMI) of 25 kg/m2 or higher and less than 40 kg/m2.
- Be between 45 and 70 years old, of any gender.
- Women should be in the postmenopausal stage.
- Use no more than three hypoglycemic medications in total.
- Be available for four consecutive weeks of hospitalization at CSVN.
You will not qualify if you...
- Use insulin, anti-obesity medications, antibiotics, or probiotic supplements within 2 months before data collection.
- Use alcohol or tobacco.
- Have limited mobility or previous diagnosis of cardiopulmonary diseases.
- Have current or recent (within 2 months) diarrhea.
- Have liver or kidney failure or uncontrolled endocrine disorders such as hypothyroidism, hypogonadism, or adrenal insufficiency.
- Have eating disorders or have undergone bariatric surgery.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universidade de São Paulo (USP)
São Paulo, São Paulo, Brazil, 01246-903
Actively Recruiting
Research Team
M
Maria E. R. Silva, MD, PhD
CONTACT
E
Edna C. Vieira, Master of Science in Nutrition
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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