Metabolomics in Prediabetes and Diabetes: A Systematic Review and Meta-analysis.
Marta Guasch-Ferré, Adela Hruby, Estefanía Toledo...
https://pubmed.ncbi.nlm.nih.gov/27208380Actively Recruiting
Phase Not Applicable
Age: 45Years - 70Years
All Genders
ID06959043
Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Led by Maria Elizabeth Rossi da Silva · Updated on 2025-05-18
60
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
M
Maria Elizabeth Rossi da Silva
Lead Sponsor
C
Clínica e Spa Vida Natural
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying how a strict vegetarian diet combined with regular physical exercise and probiotic supplements affects people with type 2 diabetes. The trial aims to understand the impact of these lifestyle changes on metabolic health, inflammation, gut microbiota, blood sugar control, body composition, insulin resistance, and quality of life. The study is randomized, double-blind, and placebo-controlled, focusing on adults between 45 and 70 years old with type 2 diabetes diagnosed within the past five years. Participants will be assigned to one of two groups. Both groups follow a strict vegetarian diet rich in fiber and bioactive compounds and engage in supervised aerobic and resistance exercise for four weeks. One group will also take a probiotic supplement twice daily, while the other group receives a placebo. After the initial intervention, participants will be monitored through telemedicine for 12 months to assess ongoing effects. Throughout the study, researchers will conduct various tests including blood sugar measurements, insulin resistance assessments, liver ultrasound and elastography, metabolomic profiling, muscle biopsies in some participants, cholesterol efflux testing, gene expression analysis, and gut microbiota evaluation using stool samples. Key outcomes include changes in body measurements, aerobic capacity, glucose control, inflammatory markers, liver function, quality of life, and depression symptoms. Follow-up evaluations will continue every three months for one year to track longer-term effects.
CONDITIONS
Brief Title
Therapeutic Strategies for Type 2 Diabetes Based on Lifestyle Changes: Plant-based Diet and Physical Exercise
Who Can Participate
Age: 45Years - 70Years
All Genders
Eligibility Criteria
You may qualify if you...
- Have a medical diagnosis of type 2 diabetes for a maximum of 5 years.
- Follow an omnivorous diet.
- Have a Body Mass Index (BMI) of at least 25 kg/m2 and less than 40 kg/m2.
- Be between 45 and 70 years old.
- Women must be in the postmenopausal stage.
- Use no more than three hypoglycemic medications.
- Be available for a four-week consecutive hospitalization at CSVN.
You will not qualify if you...
- Use insulin, anti-obesity medications, antibiotics, or probiotic supplements within 2 months before data collection.
- Use alcohol or tobacco.
- Have limited mobility or diagnosed cardiopulmonary diseases.
- Have current or recent (within 2 months) diarrhea.
- Have liver or kidney failure or uncontrolled endocrine disorders such as hypothyroidism, hypogonadism, or adrenal insufficiency.
- Have eating disorders or have undergone bariatric surgery.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 4 weeks
Participants follow a strict vegetarian diet combined with regular physical exercise for four weeks. Some participants will receive probiotic supplements twice daily, while others receive a placebo, to assess metabolic and physiological effects on type 2 diabetes.
Baseline visit and visits at 4 weeks post-intervention
Follow-up
Duration - 12 months
Participants are monitored through telemedicine visits to assess long-term changes in glycemic control, lipid profile, liver enzymes, and other health outcomes after the intervention ends.
Telemedicine visits every 3 months over 12 months
Trial Site Locations
Total: 1 location
1
Universidade de São Paulo (USP)
São Paulo, São Paulo, Brazil, 01246-903
Actively Recruiting
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Research Team
M
Maria E. R. Silva, MD, PhD
E
Edna C. Vieira, Master of Science in Nutrition
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Glyoxylate, a new marker metabolite of type 2 diabetes.
Victoria J Nikiforova, Pieter Giesbertz, Jan Wiemer...
https://pubmed.ncbi.nlm.nih.gov/25525609Impact of bacterial probiotics on obesity, diabetes and non-alcoholic fatty liver disease related variables: a systematic review and meta-analysis of randomised controlled trials.
Hana Koutnikova, Bernd Genser, Milena Monteiro-Sepulveda...
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Maryam Miraghajani, Somayeh Shahraki Dehsoukhteh, Nahid Rafie...
https://pubmed.ncbi.nlm.nih.gov/28538869GLP-1 based therapeutics: simultaneously combating T2DM and obesity.
Kristy M Heppner, Diego Perez-Tilve
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Somayyeh Firouzi, Hazreen Abdul Majid, Amin Ismail...
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https://pubmed.ncbi.nlm.nih.gov/21878448Perspective: Plant-Based Eating Pattern for Type 2 Diabetes Prevention and Treatment: Efficacy, Mechanisms, and Practical Considerations.
Meghan A Jardine, Hana Kahleova, Susan M Levin...
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https://pubmed.ncbi.nlm.nih.gov/29221645Vegetarian and vegan diets in type 2 diabetes management.
Neal D Barnard, Heather I Katcher, David J A Jenkins...
https://pubmed.ncbi.nlm.nih.gov/19386029