Clinical trial NCT05085769: Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery
Official title: Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Bariatric Surgery
Keywords: obesity
bariatric surgery
gut microbiome
diet
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 34
Sex: ALL
Minimum age (years): 26
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in gut microbial profiles of participants
timeFrame: 6 months
measure: Changes in gut bacterial biodiversity of participants
timeFrame: 6 months
Secondary outcomes:
measure: Changes in dietary energy and nutrient intakes
timeFrame: 6 months
measure: Changes in food intakes
timeFrame: 6 months
Other outcomes:
measure: Changes in body weight
timeFrame: 6 months
measure: Changes in body mass index
timeFrame: 6 months
measure: Changes in body fat and fat free mass
timeFrame: 6 months
measure: Changes in waist circumferences
timeFrame: 6 months
measure: Changes in serum glucose levels
timeFrame: 6 months
measure: Changes in lipid related biochemical parameters
timeFrame: 6 months
measure: Changes in liver function tests
timeFrame: 6 months
measure: Changes in serum IL-6 and TNF-alpha levels
timeFrame: 6 months
measure: Changes in serum hs-CRP levels
timeFrame: 6 months
Locations:
Study officials:
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