The role of intestinal bacteria in obese patients with cardiovascular risk (metabolic syndrome)

Not Applicable

• Conditions: obesity; diabetes; metabolic syndrome; C18.452.394.968.500.570

• Registration Number: RBR-2fm8j9
• Lead Sponsor: Faculdade de Medicina da Universidade São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-22
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Receivers: Caucasian women between the ages of 18 and 60 with a Body Mass Index (BMI) between 30 and 40 kg / m2 - obesity grade I and II - who meet the 2005 International Diabetes Federation (IDF) criteria for metabolic syndrome.

Exclusion Criteria

Receptors: patients with comorbidities that may interfere with data evaluation, use medications for metabolic syndrome, use antibiotics / pro-biotics in the past 90 days, previous cholecystectomy surgery, or have recent weight changes. Patients who refuse to participate in the study or who do not sign any of the terms of consent will also be excluded.
Donors: donors who have received antibiotics for the last three months, who have risky sexual behavior

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
As a primary endpoint, the variation of the mean insulin sensitivity will be evaluated, and the secondary outcomes to be evaluated will be the effect of the intervention on the composition of the intestinal microbiota, glycemic and body mass indexes and other metabolic parameters described later.<br>Increased insulin sensitivity is expected with improved glycemic control, change in faecal microbiota composition for transplanted bacteria, decreased BMI (weight loss) and improved metabolic parameters (calorimetry and bioimpedance)

Secondary Outcome Measures

Name	Time	Method
aboratory parameters:<br>Sodium, potassium, calcium, ionic calcium, phosphorus, magnesium, urea, creatinine, AST, ALT, alkaline phosphatase, gamma-GT, total bilirubin and fractions, amylase, lipase, total cholesterol and fractions, triglycerides, glucose, insulin, glycosylated hemoglobin, total protein and fractions, folic acid, vitamin B12, ferritin, serum iron, transferrin, iron binding capacity, uric acid, platelet count, C-reactive protein, TSH, total T4, free T4, GH, IGF- ACTH, cortisol, SDHEA, FSH, LH, estradiol, progesterone, free testosterone, total testosterone, androstenedione, 17-alpha-hydroxyprogesterone, prolactin, parathormone, adiponectin and leptin. All the parameters will be obtained in the pre and post transplantation aiming to establish correlation between changes in the measured values and the possible changes in the composition of the fecal microbiota.