Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoi… (NCT05372445) | Clinical Trial Compass
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 range
30 Years – 60 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical improvements in people with type 2 diabetes, prediabetes, or obesity
Timeframe: at 2 years, checked every 6 months
2
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