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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085769
• Other study ID #: GO14/533
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Obesity

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