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

Sponsor
Hacettepe University (Other)
Overall Status
Completed
CT.gov ID
NCT05085769
Collaborator
(none)
34
50

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Bariatric surgery

Study Design

Study Type:
Observational
Actual Enrollment :
34 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Potential Associations Between Alterations in Gut Microbiome and Obesity-related Traits After the Bariatric Surgery
Actual Study Start Date :
Jun 1, 2015
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Aug 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Study group

15 patients who had bariatric surgery

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.

Control group-1

8 morbidly obese participants who did not have bariatric surgery

Control group-2

11 participants who were non-obese

Outcome Measures

Primary Outcome Measures

  1. Changes in gut microbial profiles of participants [6 months]

    Changes in bacterial phyla and sub-phylum levels

  2. Changes in gut bacterial biodiversity of participants [6 months]

    Changes in gut bacterial alpha and beta biodiversity of participants

Secondary Outcome Measures

  1. Changes in dietary energy and nutrient intakes [6 months]

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

  2. Changes in food intakes [6 months]

    Changes in certain food groups in grams

Other Outcome Measures

  1. Changes in body weight [6 months]

    Changes in body weight in kilograms

  2. Changes in body mass index [6 months]

    Changes in body mass index in kg/m^2

  3. Changes in body fat and fat free mass [6 months]

    Changes in fat mass and fat free mass in kilograms

  4. Changes in waist circumferences [6 months]

    Changes in waist circumferences in centimeters

  5. Changes in serum glucose levels [6 months]

    Changes in serum glucose in mg/dL

  6. Changes in lipid related biochemical parameters [6 months]

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

  7. Changes in liver function tests [6 months]

    Changes in ALT and AST levels in U/L

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

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

  9. Changes in serum hs-CRP levels [6 months]

    Changes in serum hs-CRP in mg/L

Eligibility Criteria

Criteria

Ages Eligible for Study:
26 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Hacettepe University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Aslihan Ozdemir, Research Assistant, Hacettepe University
ClinicalTrials.gov Identifier:
NCT05085769
Other Study ID Numbers:
  • GO14/533
First Posted:
Oct 20, 2021
Last Update Posted:
Oct 20, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Aslihan Ozdemir, Research Assistant, Hacettepe University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 20, 2021