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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03178006
Other study ID # 419.676
Secondary ID
Status Completed
Phase N/A
First received June 3, 2017
Last updated June 6, 2017
Start date January 5, 2015
Est. completion date November 4, 2016

Study information

Verified date June 2017
Source Rio de Janeiro State University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This project aims to establish the correlation between intestinal microbiota with inflammatory biomarkers, intestinal morphology, vascular reactivity and degree of hepatic fibrosis in patients with different degrees of glucose tolerance and body adiposity.


Description:

Obese patients with dysglycemia or not, 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 four groups: obese with dysglycemia (OBD), obese with normoglycemia (OB), lean / overweight with dysglycemia (MD) and lean with normoglycemia (M). After the selection and signing of the informed consent, the patient will be referred for an anthropometric evaluation, with the measurement of body mass and height, waist circumference and determination of body fat by the bioimpedance method Biodynamic 450 (BioDynamics , Seattle, USA). Finally, the 24-hour reminder (R24h) will be applied as a food survey method. And the dietary calculation will be performed through the AVANUTRI® diet calculation program (Rio de Janeiro, Brazil). Clinical parameters will include: age, sex, BMI, presence of comorbidities, use of medications, gastrointestinal complaints, previous surgeries and smoking (absent, present, prior). Only after approval by the Research Ethics Committee (CEP) of the Pedro Ernesto University Hospital (HUPE-UERJ), will this recruitment begin.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date November 4, 2016
Est. primary completion date November 4, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Men or women between 18 and 50 years old

- BMI between 30-40kg / m2 with and without diabetes or altered glucose tolerance

- BMI between 18-24.9 kg / m2 without diabetes or altered glucose tolerance

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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rio de Janeiro State University

Outcome

Type Measure Description Time frame Safety issue
Primary Correlation Study in eutrophic and obese groups with normal glucose tolerance and also obese and eutrophic / overweight with dysglycemia the correlation between serum inflammatory markers, vascular reactivity, degree of hepatic inflammation / fibrosis and intestinal morphology and microbiota. 2018
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