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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06342050
Enrollment
24
Registered
2024-04-02
Start date
2024-05-14
Completion date
2025-01-31
Last updated
2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic Syndrome, Obesity

Keywords

Weight loss surgery, Bariatric surgery, Gut Microbiome, Blood Microbiome

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.

Interventions

None listed

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Gut Microbial CompositionStool samples will be collected at one time point only, within a week to their in person appointment.Gut microbial composition will be measured by performing whole metagenome sequencing in samples previously stored in Zymo stool collection tubes.
Blood Microbial CompositionBlood samples will be collected in fasting conditions at the Baseline visit.Blood microbial composition will be measured by performing 16S rRNA (ribosomal ribonucleic acid) in blood samples previously stored in Zymo blood collection tubes.
Body Weight (kg)BaselineBody weight will be measured with a calibrated SECA scale.
Body Height (meters)BaselineBody height will be measured with a stadiometer.
Fat Mass (Kg)BaselineBody fat mass will be measured by using the SECA mBCA 515.
Fat-free Mass (Kg)BaselineFat-free mass will be measured by using the SECA mBCA 515.
Body water (%)BaselineBody water percentage will be measured by using the SECA mBCA 515.
Skeletal Muscle Mass (kg)BaselineSkeletal muscle mass will be measured by using the SECA mBCA 515.
Fasting Glucose (mg/dL)BaselineFasting glucose will be measured after a 12h fast.
Fasting Insulin (mIU/L)BaselineFasting insulin will be measured after a 12h fast.
Lipopolysaccharides (%)BaselineLipopolysaccharides will be measured after a 12h fast.
Lipopolysaccharides binding protein (mIU/L)BaselineLipopolysaccharides binding protein will be measured after a 12h fast.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026