Impact of a vegetarian diet and exercise on type 2 diabetes management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effects of a strict vegetarian diet combined with regular physical exercise and probiotic supplementation on patients with type 2 diabetes mellitus. It is a randomized, double-blind, placebo-controlled study that aims to assess changes in metabolic, inflammatory, and epigenetic parameters. Participants will be monitored for improvements in glycemic control, insulin resistance, liver function, and overall quality of life through various assessments including blood tests and imaging techniques.

Why it matters

Who can join: the full rules

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.

Where it's running

• Universidade de São Paulo (USP)
  São Paulo, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Maria E. R. Silva, MD, PhD — University of Sao Paulo
• Study coordinator: Maria E. R. Silva, MD, PhD
• Email: mbeth@usp.br
• Phone: +55 11 3061-7258

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.