Clinical Trials Directory

Trials / Completed

CompletedNCT05085769

Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery

Status
Completed
Phase
Study type
Observational
Enrollment
34 (actual)
Sponsor
Hacettepe University · Academic / Other
Sex
All
Age
26 Years – 60 Years
Healthy volunteers
Accepted

Summary

This study aimed to examine the effects of obesity and bariatric surgery on gut microbiota in a Turkish population, and to contribute to the literature by bringing multi-dimensional parameters including dietary intake, metabolic and inflammatory markers. This case-control study was conducted between June 2015 and August 2019. All participants were followed during the six-month period. Face-to-face interviews and physical examinations were held, and blood and fecal samples were collected at the baseline (M0) and at the end of 3 (M3) and 6 months (M6). Dietary intakes of subjects were assessed using 24-h dietary recall method in each interview and a detailed quantitative food frequency questionnaire that involved 85 food items. Subjects were recruited to the study as three groups: 15 patients who had bariatric surgery as study group, 8 morbidly obese participants who did not have bariatric surgery as control group-1 and 11 participants who were non-obese (lean (n=5) and pre-obese (n=6)) as control group-2. All subjects in the study group had sleeve gastrectomy. Subjects in control groups were selected as age and gender matched with the participants in the study group. Individuals were excluded if (a) they were under 19 or above 65 years old, (b) they had an acute or chronic inflammatory disease, (c) they were diagnosed with infectious diseases, cancer or alcohol addiction, (d) they used antibiotics in last 3 months before the screening.

Conditions

Interventions

TypeNameDescription
PROCEDUREBariatric surgeryA procedure for morbidly obese patients whose body mass index (BMI) is higher than 40 kg/m2 or 35 kg/m2 and having comorbidities of obesity.

Timeline

Start date
2015-06-01
Primary completion
2018-09-01
Completion
2019-08-01
First posted
2021-10-20
Last updated
2021-10-20

Source: ClinicalTrials.gov record NCT05085769. Inclusion in this directory is not an endorsement.