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

Launched by NATIONAL COUNCIL OF SCIENTIFIC AND TECHNICAL RESEARCH, ARGENTINA · May 8, 2022

Keywords

ClinConnect Summary

This clinical trial, called MicrobiAr, is studying how a plant-based diet and lifestyle changes can help people with obesity, prediabetes, and type 2 diabetes improve their health. The researchers want to understand how these changes affect the gut microbiome— the community of bacteria in our intestines— and how this community evolves over two years as participants work towards better health. The aim is to see if these dietary and lifestyle adjustments can lead to remission of type 2 diabetes, meaning that participants might be able to achieve better blood sugar control without medication.

To be eligible for the study, participants must be between 18 and 75 years old and fall into specific categories: those with obesity (BMI greater than 30), prediabetes (with certain blood sugar levels), or type 2 diabetes (also with specific blood sugar levels and on metformin, a common diabetes medication). There are also criteria for people without these conditions to serve as a comparison group. Participants can expect to follow a structured program over two years, which includes guidance on diet and lifestyle, regular check-ins, and monitoring of their health indicators and gut microbiome changes. It's important to know that the study excludes individuals with certain health conditions or treatments, so those interested should review the eligibility criteria carefully.

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Eligibility 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