Exploring the gut microbiome's role in obesity and diabetes through a lifestyle intervention
MicrobiAr: Characterization and Follow-up of Microbiome and Health Indicators in Obese, Pre-Diabetes and Type 2 Diabetes Cohorts Undergoing a Plant-based Diet and Lifestyle Intervention
This study is testing how a plant-based diet can change the gut bacteria and improve health in people with obesity and diabetes over two years.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 480 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | National Council of Scientific and Technical Research, Argentina Government |
| Locations | 1 site (Capital Federal, Buenos Aires) |
| Trial ID | NCT05372445 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the gut microbiome and health indicators in individuals with obesity, prediabetes, and type 2 diabetes undergoing a lifestyle intervention focused on a plant-based diet. It consists of two stages: a cross-sectional analysis of 480 participants divided into four cohorts, and a longitudinal intervention where participants are randomly assigned to either a non-intensive or intensive follow-up program. The study aims to track changes in metabolic pathways and gut microbiota over two years, assessing the effectiveness of dietary changes on diabetes remission and overall health.
Who should consider this trial
Good fit: Ideal candidates include adults with obesity, prediabetes, or type 2 diabetes, as well as healthy individuals for comparison.
Not a fit: Patients with type 2 diabetes on medications other than metformin or those diagnosed for more than six years may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to effective dietary interventions that promote remission of type 2 diabetes and improve health outcomes for individuals with obesity and prediabetes.
How similar studies have performed: Other studies have shown promising results in using dietary interventions to influence the gut microbiome and improve metabolic health, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for control or reference group: * Subjects without type 2 diabetes, obesity, prediabetes (glucose intolerance), or metabolic syndrome * HbA1c less than 42mmol/mol (\<5.7%) * BMI between 18.5 and 24.9 Inclusion Criteria for people with obesity: * BMI greater than 30 Inclusion Criteria for people with prediabetes: * Fasting glucose between 110 and 125 mg/dl * HbA1c between 42 and 47 mmol/mol (5.7% to 6.4%) * BMI greater than 30 Inclusion Criteria for people with type 2 diabetes: * Fasting glucose \> 126 mg/dl * HbA1c \> 48mmol/mol (6.5% or higher) * BMI greater than 30 * Treatment with metformin at therapeutic dose (1500-2000 mg/day) or maximum tolerated dose. Exclusion Criteria: * Subjects with obesity, pre-diabetes medicated with metformin or another drug for diabetes or obesity * Subjects with type 2 diabetes medicated with another drug that is not metformin * Subjects with type 2 diabetes diagnosed over 6 years * Subjects with type 2 diabetes requiring insulin * Chronic kidney disease grade greater than 3 (measured by EPI) * Subjects with type 1 diabetes * Intestinal diseases, Crohn's, ulcerative colitis, celiac disease * Use of antibiotics in the last 3 months * Pregnancy, lactation * Psychiatric disorders * Eating disorder * Gastric bypass surgery * Transplanted people * Oncological pathology diagnosed less than 5 years * Subjects who do not wish to sign the informed consent * Subjects who do not agree to participate in the study over the 2 years follow-up * Subjects who do not have electronic devices and the internet to hold virtual meetings
Where this trial is running
Capital Federal, Buenos Aires
- Hospital de Clínicas "José de San Martín" — Capital Federal, Buenos Aires, Argentina (Recruiting)
Study contacts
- Principal investigator: Juan Bustamante, PhD — CONICET Researcher
- Study coordinator: Juan Bustamante, PhD
- Email: bustamante.bio@gmail.com
- Phone: +541164419444
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.