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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obesity, Bariatric Surgery

Intervention / Treatment
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* Procedure: Bariatric surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>15 patients who had bariatric surgery | Procedure: Bariatric surgery<br>* 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.<br>|
| Control group-1<br>8 morbidly obese participants who did not have bariatric surgery | |
| Control group-2<br>11 participants who were non-obese | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in gut microbial profiles of participants | Changes in bacterial phyla and sub-phylum levels | 6 months | 
| Changes in gut bacterial biodiversity of participants | Changes in gut bacterial alpha and beta biodiversity of participants | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in dietary energy and nutrient intakes | Changes in dietary energy in calories, macro-, micronutrient intakes in grams | 6 months | 
| Changes in food intakes | Changes in certain food groups in grams | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, gut microbiome, diet, obesity