Clinical trial NCT06342050: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS
Official title: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-Operative Weight Loss (Substudy)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Metabolic Syndrome
Keywords: Weight loss surgery
Bariatric surgery
Gut Microbiome
Blood Microbiome
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-04-02
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will recruit in the following manner:

* Non-surgery participants from the "non-completers" group from the main study
* Participants who had bariatric surgery 6 months prior to their enrollment into this sub study, will be recruited from the "early and late completers" in the main study. If additional participants are needed, particularly due to strict ethnic requirements (limited to NHW and NHB), first, invitation emails will be sent to the Weight Wellness Clinic patients, and if recruiting at the expected rate continues to be an issue, advertisements through IRB-approved flyers on social media or in the clinic setting will be posted.

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Gut Microbial Composition
timeFrame: Stool samples will be collected at one time point only, within a week to their in person appointment.
measure: Blood Microbial Composition
timeFrame: Blood samples will be collected in fasting conditions at the Baseline visit.
measure: Body Weight (kg)
timeFrame: Baseline
measure: Body Height (meters)
timeFrame: Baseline
measure: Fat Mass (Kg)
timeFrame: Baseline
measure: Fat-free Mass (Kg)
timeFrame: Baseline
measure: Body water (%)
timeFrame: Baseline
measure: Skeletal Muscle Mass (kg)
timeFrame: Baseline
measure: Fasting Glucose (mg/dL)
timeFrame: Baseline
measure: Fasting Insulin (mIU/L)
timeFrame: Baseline
measure: Lipopolysaccharides (%)
timeFrame: Baseline
measure: Lipopolysaccharides binding protein (mIU/L)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Benjamin Schneider, M.D.
role: PRINCIPAL_INVESTIGATOR
References: