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New treatment option for Type 2 Diabetes Mellitus (T2DM)
Official title Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
ClinicalTrials.gov ID: NCT06959043
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 70
You may be able to join if
- 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;
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.