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

Last updated: May 20, 2025
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

N/A

Condition

Obesity

High Cholesterol (Hyperlipidemia)

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT06342050
STU-2023-0548
R01MD011686
  • Ages 18-60
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18-60 years old

  • Will belong to either Non-Hispanic Whites (NHW) or Non-Hispanic Blacks (NHB) ethnicgroups

  • "No-WLS" participants will have a BMI >35 kg/m2 (threshold BMI for WLS) whereas "6months post-WLS" participants will have no BMI requirements.

Exclusion

Exclusion Criteria:

  • Having taken antibiotics in the previous 6 months;

  • Metformin, proton pump inhibitors, probiotics, or prebiotics in the previous month;

  • Currently following a vegetarian diet;

  • Pregnancy;

  • Having any infection in the previous month; and

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

Study Design

Total Participants: 24
Study Start date:
May 14, 2024
Estimated Completion Date:
January 31, 2025

Study Description

A subgroup of participants from the main study will be invited to participate in a cross-sectional sub study evaluating the relationship between blood and gut microbiotas. A total of 100 participants will be recruited, 50 participants will be recruited from the "non-completers" and the other 50 participants will be recruited from the "6 months post-WLS" follow-up group of our main project.

Connect with a study center

  • UT Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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