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

Correlation Between Intestinal Microbiota, Inflamatory Biomarkers, Intestinal Morphology, Hepatic Fibrosis Degree and Vascular Reactivity in Patients With Different Degrees of Glucose Tolerance and Body Adiposity.

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.

Study Overview

• Status: Completed
• Conditions: Microbial Colonization

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 Type: Observational
• Enrollment (Actual): 47

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obese patients with dysglycemia or not from the Obesity Clinic from UERJ will be invited to participate in the study, and individuals with normal or overweight weight with dysglycemia or not, preferably from the same social class and type of diet of the obese

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
obese plus diabetes,; BMI 30-40kg/m2 and diabetes or pre-diabetes
obese; BMI 30-40kg/m2
control; BMI 20-27,5kg/m2

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation	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.	2018

Collaborators and Investigators

• Sponsor: Rio de Janeiro State University

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2015
• Primary Completion (Actual): November 4, 2016
• Study Completion (Actual): November 4, 2016

Study Registration Dates

• First Submitted: June 3, 2017
• First Submitted That Met QC Criteria: June 3, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): June 8, 2017
• Last Update Submitted That Met QC Criteria: June 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases
• Other Study ID Numbers: 419.676

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No