Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS
- Conditions
- ObesityMetabolic Syndrome
- Registration Number
- NCT06342050
- Lead Sponsor
- University of Texas Southwestern Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Gut Microbial Composition Stool 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.
Fasting Glucose (mg/dL) Baseline Fasting glucose will be measured after a 12h fast.
Blood Microbial Composition Blood 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 Height (meters) Baseline Body height will be measured with a stadiometer.
Fat Mass (Kg) Baseline Body fat mass will be measured by using the SECA mBCA 515.
Skeletal Muscle Mass (kg) Baseline Skeletal muscle mass will be measured by using the SECA mBCA 515.
Fasting Insulin (mIU/L) Baseline Fasting insulin will be measured after a 12h fast.
Body water (%) Baseline Body water percentage will be measured by using the SECA mBCA 515.
Lipopolysaccharides (%) Baseline Lipopolysaccharides will be measured after a 12h fast.
Body Weight (kg) Baseline Body weight will be measured with a calibrated SECA scale.
Fat-free Mass (Kg) Baseline Fat-free mass will be measured by using the SECA mBCA 515.
Lipopolysaccharides binding protein (mIU/L) Baseline Lipopolysaccharides binding protein will be measured after a 12h fast.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
UT Southwestern Medical Center
🇺🇸Dallas, Texas, United States