Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention (MicrobiAr)
Diabetes Mellitus, Type 2, Obesity, PreDiabetes
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring microbiota, microbiome, plant-based diet, type 2 diabetes remission, metabolic syndrome, caloric restriction, metabolic pathways
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
Sites / Locations
- Hospital de Clínicas "José de San Martín"Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
No Intervention
Active Comparator
Experimental
Active Comparator
Experimental
Active Comparator
Experimental
Reference Group
Obesity Group A
Obesity Group B
Prediabetes Group A
Prediabetes Group B
Type 2 Diabetes Group A
Type 2 Diabetes Group B
People between 30-60 years old, without obesity, prediabetes or type 2 diabetes. The purpose of this group is to characterize gut microbiota and microbiome to set the reference values of the argentinian local population.
People between 30-60 years old, diagnosed with obesity assigned to the non-intensive intervention.
People between 30-60 years old, diagnosed with obesity assigned to the intensive intervention.
People between 30-60 years old, diagnosed with prediabetes assigned to the non-intensive intervention.
People between 30-60 years old, diagnosed with prediabetes assigned to the intensive intervention.
People between 30-60 years old, diagnosed with type 2 diabetes assigned to the non-intensive intervention.
People between 30-60 years old, diagnosed with type 2 diabetes assigned to the intensive intervention.