Impact of a vegetarian diet and exercise on type 2 diabetes management
Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
This study is testing whether a strict vegetarian diet and regular exercise can help people with type 2 diabetes manage their condition better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 45 Years to 70 Years |
| Sex | All |
| Sponsor | University of Sao Paulo General Hospital Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06959043 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 45 to 70 with a recent diagnosis of type 2 diabetes and a BMI between 25 and 40.
Not a fit: Patients using insulin, anti-obesity medications, or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glycemic control and overall health in patients with type 2 diabetes.
How similar studies have performed: Previous studies have shown promising results with lifestyle interventions in managing type 2 diabetes, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
São Paulo, São Paulo
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.