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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05085769
Enrollment
34
Registered
2021-10-20
Start date
2015-06-01
Completion date
2019-08-01
Last updated
2021-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bariatric Surgery, Obesity

Keywords

obesity, bariatric surgery, gut microbiome, diet

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.

Interventions

PROCEDUREBariatric 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.

Sponsors

Hacettepe University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
26 Years to 60 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Changes in gut microbial profiles of participants6 monthsChanges in bacterial phyla and sub-phylum levels
Changes in gut bacterial biodiversity of participants6 monthsChanges in gut bacterial alpha and beta biodiversity of participants

Secondary

MeasureTime frameDescription
Changes in dietary energy and nutrient intakes6 monthsChanges in dietary energy in calories, macro-, micronutrient intakes in grams
Changes in food intakes6 monthsChanges in certain food groups in grams

Other

MeasureTime frameDescription
Changes in serum glucose levels6 monthsChanges in serum glucose in mg/dL
Changes in lipid related biochemical parameters6 monthsChanges in triglyceride, total cholesterol, LDL cholesterol, HDL cholesterol levels in mg/dL
Changes in body weight6 monthsChanges in body weight in kilograms
Changes in serum IL-6 and TNF-alpha levels6 monthsChanges in serum IL-6 and TNF-alpha levels in ng/mL
Changes in serum hs-CRP levels6 monthsChanges in serum hs-CRP in mg/L
Changes in liver function tests6 monthsChanges in ALT and AST levels in U/L
Changes in body mass index6 monthsChanges in body mass index in kg/m\^2
Changes in body fat and fat free mass6 monthsChanges in fat mass and fat free mass in kilograms
Changes in waist circumferences6 monthsChanges in waist circumferences in centimeters

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026