TerminatedNot Applicable

Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention

Stopped: Recruitment was discontinued due to Argentina severe socio-economic crisis, which significantly impacted hospital operations and research funding. The loss of financial support prevented further enrollment and coverage of clinical and lab assessments

Argentina468 participantsStarted 2022-05-30

Plain-language summary

The incidence of type 2 diabetes worldwide is growing rapidly, being one of the fastest growing global health emergencies of the 21st century according to the International Diabetes Federation. In MicrobiAr the investigators seek to achieve type 2 diabetes remission through a plant-based diet and lifestyle intervention identifying and characterizing key changes on the gut microbiome during clinical transitions. Specifically, the investigators aim to characterize and follow-up metabolic pathways from gut microbiome and how they evolve as long as health indicators do over the 2 years of this study.

Who can participate

Age range30 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 yea…

What they're measuring

Clinical improvements in people with type 2 diabetes, prediabetes, or obesity

Timeframe: at 2 years, checked every 6 months

Gut microbiota metabolic pathways changes

Timeframe: at 2 years, checked every 6 months

Trial details

NCT IDNCT05372445

SponsorNational Council of Scientific and Technical Research, Argentina

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials