Actively Recruiting

Phase Not Applicable
Age: 45Years - 70Years
All Genders
NCT06959043

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

Age: 45Years - 70Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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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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