Microbial ColonizationNCT03178006
Correlation Between Intestinal Microbiota, Inflamatory Biomarkers, Intestinal Morphology, Hepatic Fibrosis Degree and Vascular Reactivity.
An observational study of Microbial Colonization, run by Rio de Janeiro State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Microbial Colonization
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- 5 Jan 2015to 4 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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
Who may be able to join
- Healthy men or women between 18 and 50 years old
- Individuals with obesity and normoglycemia
- Individuals with obesity and dysglycemia
Who cannot join
- 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)
Show all 10Show fewer
- Positive tests for HIV infection and hepatitis B and C;
- Pregnant and lactating women;
- Smokers
- Chronic alcoholism.
About this study
Official title: 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.
Read the 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
- Medical subject headings
- Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start5 Jan 2015
- Primary completion4 Nov 2016
- Study completion4 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Microbial ColonizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Guilherme Kraemer-Aguiar, MD, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03178006
- Sponsor's protocol ID
- 419.676
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2017
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT03178006
- Acronym / sponsor ID
- 419.676
- Conditions
- Microbial Colonization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 4 Nov 2016 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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
Key inclusion criteria (3 listed)
- Healthy men or women between 18 and 50 years old
- Individuals with obesity and normoglycemia
- Individuals with obesity and dysglycemia
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation
Time frame: 2018
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Microbial Colonization
Not yet recruitingObservational study
Arterial Stiffness During Negative Pressure Wound Therapy for Abdominal Wall Wounds
Postoperative Abdominal Wall Wound Complications, Surgical Wound Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
Active, not recruiting
Barrier-Protect Study
Infection
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Microbial Colonization, run by Rio de Janeiro State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation (time frame: 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2025.