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NCT06342050Completed

Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS

Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-Operative Weight Loss (Substudy)

Source: ClinicalTrials.gov · Last updated 22 May 2025

Brief summary (registry, in English)

The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS. The main aims / objectives of this sub-study are: * Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants. Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory. * Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups. Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups.

Status (registry)
Completed
Study type
Observational
Enrollment
24 (actual)
First submitted
22 Feb 2024
Start date
14 May 2024
Primary completion date
31 Jan 2025
Lead sponsor
University of Texas Southwestern Medical Center
Diseases
Obesity
NCT number
NCT06342050

What you commit to

  • Study type: Observational
  • Participants enrolled: 24
  • From 14 May 2024 to the primary completion date, 31 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Having taken antibiotics in the previous 6 months;
  • Metformin, proton pump inhibitors, probiotics, or prebiotics in the previous month;
  • Having any infection in the previous month; and

Other illness

  • Having a comorbid disease that might alter the blood microbiome composition (e.g., renal failure) or the intestinal permeability (e.g., IBS).

Other

  • Currently following a vegetarian diet;
  • Pregnancy;

Who the study is looking for

  • 18-60 years old
  • Will belong to either Non-Hispanic Whites (NHW) or Non-Hispanic Blacks (NHB) ethnic groups
  • "No-WLS" participants will have a BMI \>35 kg/m2 (threshold BMI for WLS) whereas "6 months post-WLS" participants will have no BMI requirements.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UT Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.