Status:
UNKNOWN
Microbiome and Health Indicators in People With Obesity, Prediabetes and Type 2 Diabetes Undergoing a Lifestyle Intervention
Lead Sponsor:
National Council of Scientific and Technical Research, Argentina
Collaborating Sponsors:
Facultad de Ingeniería - Universidad Austral
Instituto de Inmunología, Genética y Metabolismo (INIGEM, CONICET-UBA)
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
30-60 years
Phase:
NA
Brief 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 Mic...
Detailed Description
The present study has 2 stages, one cross-sectional and the other longitudinal. In the cross-sectional stage, a characterization of a single sampling of 480 people divided into 4 cohorts of 120 people...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 30 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT05372445
Start Date
May 30 2022
End Date
December 1 2025
Last Update
August 1 2022
Active Locations (1)
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1
Hospital de Clínicas "José de San Martín"
Capital Federal, Buenos Aires, Argentina, C1120AAR