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

Obesity Clinical Trial

Official title:

Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-Operative Weight Loss (Substudy)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06342050
• Other study ID #: STU-2023-0548
• Secondary ID: R01MD011686
• Status: Recruiting
• Start date: May 14, 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Morgan Marsh
• Phone: 214/648-8568
• Email: Morgan.Marsh[@]UTSouthwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Metabolic Syndrome
• Obesity

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

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