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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05085769
Other study ID # GO14/533
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2015
Est. completion date August 1, 2019

Study information

Verified date October 2021
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 1, 2019
Est. primary completion date September 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 26 Years to 60 Years
Eligibility Inclusion Criteria: - morbidly obese participants for study and control group-1 - non-obese participants for control group-2 Exclusion Criteria: - they were under 19 or above 65 years old, - they had an acute or chronic inflammatory disease, - they were diagnosed with infectious diseases, cancer or alcohol addiction, - they used antibiotics in last 3 months before the screening.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Bariatric surgery
A 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hacettepe University

Outcome

Type Measure Description Time frame Safety issue
Other Changes in body weight Changes in body weight in kilograms 6 months
Other Changes in body mass index Changes in body mass index in kg/m^2 6 months
Other Changes in body fat and fat free mass Changes in fat mass and fat free mass in kilograms 6 months
Other Changes in waist circumferences Changes in waist circumferences in centimeters 6 months
Other Changes in serum glucose levels Changes in serum glucose in mg/dL 6 months
Other Changes in lipid related biochemical parameters Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mg/dL 6 months
Other Changes in liver function tests Changes in ALT and AST levels in U/L 6 months
Other Changes in serum IL-6 and TNF-alpha levels Changes in serum IL-6 and TNF-alpha levels in ng/mL 6 months
Other Changes in serum hs-CRP levels Changes in serum hs-CRP in mg/L 6 months
Primary Changes in gut microbial profiles of participants Changes in bacterial phyla and sub-phylum levels 6 months
Primary Changes in gut bacterial biodiversity of participants Changes in gut bacterial alpha and beta biodiversity of participants 6 months
Secondary Changes in dietary energy and nutrient intakes Changes in dietary energy in calories, macro-, micronutrient intakes in grams 6 months
Secondary Changes in food intakes Changes in certain food groups in grams 6 months
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