Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Launched by MARIA ELIZABETH ROSSI DA SILVA · Apr 27, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is exploring how a strict vegetarian diet, regular exercise, and probiotics can help people with type 2 diabetes improve their health. The researchers want to see if these lifestyle changes can positively affect things like blood sugar control, body weight, and overall well-being. By focusing on diet and exercise, they hope to learn more about how these factors influence the bacteria in our gut, which can play a big role in our health.
To participate in this study, you need to be between 45 and 70 years old, have been diagnosed with type 2 diabetes for five years or less, and meet certain health criteria, including having a body mass index (BMI) between 25 and 40. Women must be postmenopausal, and you should not be using insulin or certain medications. If eligible, you can expect to spend four weeks in a hospital setting where you’ll follow the vegetarian diet and exercise plan. This trial is currently looking for participants, so it could be a great opportunity to improve your health while contributing to important research.
Gender
ALL
Eligibility 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.
About Maria Elizabeth Rossi Da Silva
Maria Elizabeth Rossi da Silva is a dedicated clinical trial sponsor with a commitment to advancing medical research and improving patient outcomes. With a strong background in clinical development and regulatory compliance, she oversees the design, implementation, and management of innovative clinical trials across various therapeutic areas. Her focus on collaboration and ethical practices ensures that trials are conducted with the highest standards of integrity and scientific rigor. Through her leadership, Maria aims to facilitate the translation of groundbreaking research into effective therapies that address unmet medical needs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
São Paulo, , Brazil
Patients applied
Trial Officials
Maria E. R. Silva, MD, PhD
Principal Investigator
University of Sao Paulo
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported