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

The University of Texas System (UT)

Status: Completed

Conditions: Obesity; Metabolic Syndrome

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06342050

STU-2023-0548

R01MD011686 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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).

Trial design

24 participants in 2 patient groups

WLS non-completers

Description:

Participants who did not have WLS as part of the main study

WLS completers

Description:

Participants who had WLS as part of the main study