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

NCT05085769 | Completed

• 1 other identifier: GO14/533
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Obesity; Bariatric Surgery

Keywords

obesity; bariatric surgery; gut microbiome; diet

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in dietary energy and nutrient intakes

  6 months

• Changes in food intakes

  6 months

Other Outcomes (9)

• Changes in body weight

  6 months

• Changes in body mass index

  6 months

• Changes in body fat and fat free mass

  6 months

Study Arms (3)

Study group

15 patients who had bariatric surgery

Procedure: Bariatric surgery

Control group-1

8 morbidly obese participants who did not have bariatric surgery

Control group-2

11 participants who were non-obese

Interventions

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.

Study group

Eligibility Criteria

• Age: 26 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• morbidly obese participants for study and control group-1
• non-obese participants for control group-2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hacettepe University: lead

Related Publications (1)

• Ozdemir A, Sarzhanov F, Dogruman-Al F, Gundogdu A, Nalbantoglu U, Yozgat A, Yildiz BD, Buyuktuncer Z. Exploring the complex interplay of Blastocystis, morbid obesity, and bariatric surgery on gut microbial dynamics. Microb Pathog. 2025 Mar;200:107306. doi: 10.1016/j.micpath.2025.107306. Epub 2025 Jan 15.

  PMID: 39824262 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: October 20, 2021
• Study Start: June 1, 2015
• Primary Completion: September 1, 2018
• Study Completion: August 1, 2019
• Last Updated: October 20, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share