Status:
RECRUITING
Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Lead Sponsor:
Maria Elizabeth Rossi da Silva
Collaborating Sponsors:
Clínica e Spa Vida Natural
Probiotical Spa
Conditions:
Type 2 Diabetes Mellitus (T2DM)
Insulin Resistance
Eligibility:
All Genders
45-70 years
Phase:
NA
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...
Detailed Description
This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the effects of a strict vegetarian diet (SVD) combined with regular physical exercise (RPE), with or without probiotic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06959043
Start Date
November 22 2022
End Date
December 1 2026
Last Update
May 18 2025
Active Locations (1)
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1
Universidade de São Paulo (USP)
São Paulo, São Paulo, Brazil, 01246-903