Correlation Between Intestinal Microbiota, Inflamatory Biomarkers, Intestinal Morphology, Hepatic Fibrosis Degree and Vascular Reactivity.

Completed

• Conditions: Microbial Colonization

• Registration Number: NCT03178006
• Lead Sponsor: Rio de Janeiro State University

Brief Summary

This project aims to establish the correlation between intestinal microbiota with inflammatory biomarkers, intestinal morphology, vascular reactivity and degree of hepatic fibrosis in patients with different degrees of glucose tolerance and body adiposity.

Detailed Description

Obese patients with dysglycemia or not, from the Obesity Outpatient Clinic, and individuals with normal or overweight weight with dysglycemia or not, preferably from the same social class and type of diet of the obese will be invited to participate in the study. Dysglycemia will be defined by the criteria of the Brazilian Society of Diabetes. These individuals will be divided into four groups: obese with dysglycemia (OBD), obese with normoglycemia (OB), lean / overweight with dysglycemia (MD) and lean with normoglycemia (M). After the selection and signing of the informed consent, the patient will be referred for an anthropometric evaluation, with the measurement of body mass and height, waist circumference and determination of body fat by the bioimpedance method Biodynamic 450 (BioDynamics , Seattle, USA). Finally, the 24-hour reminder (R24h) will be applied as a food survey method. And the dietary calculation will be performed through the AVANUTRI® diet calculation program (Rio de Janeiro, Brazil). Clinical parameters will include: age, sex, BMI, presence of comorbidities, use of medications, gastrointestinal complaints, previous surgeries and smoking (absent, present, prior). Only after approval by the Research Ethics Committee (CEP) of the Pedro Ernesto University Hospital (HUPE-UERJ), will this recruitment begin.

Study Timeline

• Study Start: 2015-01-05
• Primary Completion: 2016-11-04
• Study Completion: 2016-11-04
• Status Verified: 2017-06
• Study First Submitted: 2017-06-03
• Study First Submitted QC: 2017-06-03
• Study First Posted: 2017-06-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Men or women between 18 and 50 years old
• BMI between 30-40kg / m2 with and without diabetes or altered glucose tolerance
• BMI between 18-24.9 kg / m2 without diabetes or altered glucose tolerance

Exclusion Criteria

• Acute disease
• Chronic pulmonary, cardiovascular, haematological, gastrointestinal, hepatic or renal diseases;
• Unstable dietary history, defined as major changes in diet during the previous month diagnosed by a specialist nutritionist;
• History of gastrointestinal disturbances in activity or chronic diseases, including - inflammatory bowel diseases (IBD), chronic diarrhea of unknown etiology, chronic constipation, disabsorbing syndromes,
• History of major gastrointestinal tract surgery, except cholecystectomy and appendectomy;
• Use of the following medications: probiotics in the last 6 months, systemic antibiotics, oral corticosteroids, cytokines, methotrexate or cytotoxic immunosuppressive agents, consumption of large doses of commercial probiotics (greater than or equal to 10 8 CFU or organisms per day)
• Positive tests for HIV infection and hepatitis B and C;
• Pregnant and lactating women;
• Smokers
• Chronic alcoholism.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation	2018	Study in eutrophic and obese groups with normal glucose tolerance and also obese and eutrophic / overweight with dysglycemia the correlation between serum inflammatory markers, vascular reactivity, degree of hepatic inflammation / fibrosis and intestinal morphology and microbiota.