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

NCT ID: NCT03178006

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-05
• Study Completion Date: 2016-11-04

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.

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

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

healthy controls

healthy individuals

No interventions assigned to this group

patients with obesity and dysglycemia

Individuals with BMI \> 30 kg/m2 and dysglycemia

No interventions assigned to this group

patients with obesity and normoglycemia

Individuals with BMI \> 30 kg/m2 and normoglycemia

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rio de Janeiro State University

OTHER

Sponsor Role: lead

Responsible Party

Luiz Guilherme Kraemer-Aguiar, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

419.676

Identifier Type: -

Identifier Source: org_study_id