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

NCT03178006 | Completed

• 1 other identifier: 419.676
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Microbial Colonization

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rio de Janeiro State University: lead

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2017
• First Posted: June 6, 2017
• Study Start: January 5, 2015
• Primary Completion: November 4, 2016
• Study Completion: November 4, 2016
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share