Microbial Colonization Clinical Trial
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.
Verified date | June 2017 |
Source | Rio de Janeiro State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Rio de Janeiro State University |
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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