NCT03178006

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.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 46 (actual)
• Sponsor: Rio de Janeiro State University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Microbial Colonization

Timeline

• Start date: 2015-01-05
• Primary completion: 2016-11-04
• Completion: 2016-11-04
• First posted: 2017-06-06
• Last updated: 2025-07-02