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Completed

NCT Number: NCT05085769

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

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bariatric surgery

Procedure

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.

Primary outcomes

  1. Changes in gut microbial profiles of participants

    Time frame: 6 months

    Changes in bacterial phyla and sub-phylum levels

  2. Changes in gut bacterial biodiversity of participants

    Time frame: 6 months

    Changes in gut bacterial alpha and beta biodiversity of participants

Secondary outcomes

  1. Changes in dietary energy and nutrient intakes

    Time frame: 6 months

    Changes in dietary energy in calories, macro-, micronutrient intakes in grams

  2. Changes in food intakes

    Time frame: 6 months

    Changes in certain food groups in grams

Other outcomes

  1. Changes in body weight

    Time frame: 6 months

    Changes in body weight in kilograms

  2. Changes in body mass index

    Time frame: 6 months

    Changes in body mass index in kg/m^2

  3. Changes in body fat and fat free mass

    Time frame: 6 months

    Changes in fat mass and fat free mass in kilograms

  4. Changes in waist circumferences

    Time frame: 6 months

    Changes in waist circumferences in centimeters

  5. Changes in serum glucose levels

    Time frame: 6 months

    Changes in serum glucose in mg/dL

  6. Changes in lipid related biochemical parameters

    Time frame: 6 months

    Changes in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mg/dL

  7. Changes in liver function tests

    Time frame: 6 months

    Changes in ALT and AST levels in U/L

  8. Changes in serum IL-6 and TNF-alpha levels

    Time frame: 6 months

    Changes in serum IL-6 and TNF-alpha levels in ng/mL

  9. Changes in serum hs-CRP levels

    Time frame: 6 months

    Changes in serum hs-CRP in mg/L

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Oct 20, 2021
Registry last updated
Oct 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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