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.

Metabolic, inflammatory status, intestinal permeability biomarkers, and gut microbiota composition were investigated in individuals with varying levels of adiposity and glucose tolerance. This project focuses on exploring the associations between gut permeability and metabolic profiles.

Study Overview

• Status: Completed
• Conditions: Microbial Colonization

Detailed Description

Obese patients with varying levels of adiposity and glucose tolerance 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 three groups: lean controls with normoglycemia (CON), patients with obesity and normoglycemia (NOB), and obesity and dysglycemia (DOB). Biochemical/inflammatory biomarkers, like lipopolysaccharide (LPS) and LPS binding protein (LBP), will be assessed. Duodenal biopsies will be assessed by upper digestive videoendoscopy. Histomorphometry, expression of junctional and cytoskeleton proteins, and enzymatic activity of duodenal epithelium will be used as markers of intestinal permeability. Fecal microbiota composition (FMC) will be analyzed by amplifying the V4 region of the 16S rRNA gene, which will be sequenced with next-generation sequencing technology. 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): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

• 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:

• Healthy men or women between 18 and 50 years old
• Individuals with obesity and normoglycemia
• Individuals with obesity and dysglycemia

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
healthy controls; healthy individuals
patients with obesity and dysglycemia; Individuals with BMI > 30 kg/m2 and dysglycemia
patients with obesity and normoglycemia; Individuals with BMI > 30 kg/m2 and normoglycemia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation	We hypothesize that greater glucose intolerance and obesity are associated with higher epithelial barrier dysfunction and changes in fecal microbiota composition (FMC). We investigated the metabolic and inflammatory biomarkers, intestinal permeability, and FMC in normoglycemic controls versus normoglycemic and dysglycemic individuals with obesity. Specifically, we tested the associations between intestinal permeability and metabolic markers.	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): July 2, 2025
• Last Update Submitted That Met QC Criteria: June 29, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No