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Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
RECRUITINGN/ASponsored by Maria Elizabeth Rossi da Silva
Actively Recruiting
PhaseN/A
SponsorMaria Elizabeth Rossi da Silva
Started2022-11-22
Est. completion2025-08
Eligibility
Age45 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06959043
Summary
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.
Eligibility
Age: 45 Years – 70 YearsHealthy volunteers accepted
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.
Conditions5
DiabetesGut MicrobiomesInflamationInsulin ResistanceType 2 Diabetes Mellitus (T2DM)
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Actively Recruiting
PhaseN/A
SponsorMaria Elizabeth Rossi da Silva
Started2022-11-22
Est. completion2025-08
Eligibility
Age45 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06959043