Status:
UNKNOWN
Probiotics on Body Composition and Insulin Resistance in Patients With Obesity and Its Association With Gut Microbiota
Lead Sponsor:
Hospital General de México Dr. Eduardo Liceaga
Collaborating Sponsors:
Italmex Pharma
Medix Farma
Conditions:
Obesity
Insulin Resistance
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
This study aims to evaluate the modifications in body composition and insulin resistance state in patients with grade II and III obesity included in an interventional lifestyle changes program and tre...
Detailed Description
A randomized placebo-controlled clinical trial will take place in which both arms will be included in an interventional lifestyle changes program at the Clinic for Integral Treatment of patients with ...
Eligibility Criteria
Inclusion
- Patients with grade II y III obesity (IMC \> or = 35 Kg/m2), who receive the initial evaluation at the Integral Attention Clinic for Diabetes and Obesity at Hospital General de México
- Patients who signed informed consent.
Exclusion
- Diabetes mellitus 2
- Secondary causes of obesity (hypothyroidism, Cushing syndrome).
- Patients receiving pharmacological treatment that may affect lipid or glucose metabolism.
- Patients who received broad-spectrum antibiotics during the 4 previous weeks.
- Ingestion of products that contain probiotics.
- Relevant changes in diet habits during the 4 previous weeks
- Intestinal Malabsorption disorders ( inflammatory bowel disease, chronic diarrhea, C. difficile infection).
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04086173
Start Date
March 1 2018
End Date
July 31 2020
Last Update
September 11 2019
Active Locations (1)
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1
Hospital General de México "Dr. Eduardo Liceaga"
Mexico City, Mexico