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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: t
View:

• 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

• BMI greater than 30

• Fasting glucose between 110 and 125 mg/dl

• HbA1c between 42 and 47 mmol/mol (5.7% to 6.4%)

• BMI greater than 30

• 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.

Locations
Other Locations
Argentina
Hospital de Clínicas José de San Martín
RECRUITING
Capital Federal
Contact Information
Primary
Juan Bustamante, PhD
bustamante.bio@gmail.com
+541164419444
Backup
Gustavo Frechtel, PhD
gfrechtel@yahoo.com
+541154066193
Time Frame
Start Date: 2022-05-30
Estimated Completion Date: 2025-12
Participants
Target number of participants: 480
Treatments
No_intervention: Reference Group
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.
Active_comparator: Obesity Group A
People between 30-60 years old, diagnosed with obesity assigned to the non-intensive intervention.
Experimental: Obesity Group B
People between 30-60 years old, diagnosed with obesity assigned to the intensive intervention.
Active_comparator: Prediabetes Group A
People between 30-60 years old, diagnosed with prediabetes assigned to the non-intensive intervention.
Experimental: Prediabetes Group B
People between 30-60 years old, diagnosed with prediabetes assigned to the intensive intervention.
Active_comparator: Type 2 Diabetes Group A
People between 30-60 years old, diagnosed with type 2 diabetes assigned to the non-intensive intervention.
Experimental: Type 2 Diabetes Group B
People between 30-60 years old, diagnosed with type 2 diabetes assigned to the intensive intervention.
Related Therapeutic Areas
Sponsors
Collaborators: Facultad de Ingeniería - Universidad Austral, Instituto de Investigación y Desarrollo en Bioingeniería y Bioinformática (IBB, CONICET-UNER), Zymo Research, Instituto de Inmunología, Genética y Metabolismo (INIGEM, CONICET-UBA), Illumina, Inc.
Leads: National Council of Scientific and Technical Research, Argentina

This content was sourced from clinicaltrials.gov