ObesityNCT06342050
Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-WLS
An observational study of Obesity and Metabolic Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Metabolic Syndrome
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-Operative Weight Loss (Substudy)
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:
Read more
- 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.
Read the 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.
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Weight loss surgery, Bariatric surgery, Gut Microbiome, Blood Microbiome
- Medical subject headings
- Obesity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| WLS non-completers | Participants who did not have WLS as part of the main study | |
| WLS completers | Participants who had WLS as part of the main study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gut Microbial Composition
Gut microbial composition will be measured by performing whole metagenome sequencing in samples previously stored in Zymo stool collection tubes.
Measured: Stool samples will be collected at one time point only, within a week to their in person appointment.
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.
Measured: Blood samples will be collected in fasting conditions at the Baseline visit.
Body Weight (kg)
Body weight will be measured with a calibrated SECA scale.
Measured: Baseline
Body Height (meters)
Body height will be measured with a stadiometer.
Measured: Baseline
Fat Mass (Kg)
Body fat mass will be measured by using the SECA mBCA 515.
Measured: Baseline
Fat-free Mass (Kg)
Fat-free mass will be measured by using the SECA mBCA 515.
Measured: Baseline
Body water (%)
Body water percentage will be measured by using the SECA mBCA 515.
Measured: Baseline
Skeletal Muscle Mass (kg)
Skeletal muscle mass will be measured by using the SECA mBCA 515.
Measured: Baseline
Fasting Glucose (mg/dL)
Fasting glucose will be measured after a 12h fast.
Measured: Baseline
Fasting Insulin (mIU/L)
Fasting insulin will be measured after a 12h fast.
Measured: Baseline
Lipopolysaccharides (%)
Lipopolysaccharides will be measured after a 12h fast.
Measured: Baseline
Lipopolysaccharides binding protein (mIU/L)
Lipopolysaccharides binding protein will be measured after a 12h fast.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start14 May 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Benjamin Schneider, University of Texas Southwestern Medical Center
- Investigators
- Benjamin Schneider, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342050
- Sponsor's protocol ID
- STU-2023-0548
- Other IDs
- R01MD011686
- Status last verified
- May 2025
- First submitted
- 22 Feb 2024
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-Operative Weight Loss (Substudy)
- ClinicalTrials.gov ID
- NCT06342050
- Acronym / sponsor ID
- STU-2023-0548
- Conditions
- Obesity, Metabolic Syndrome
- Keywords
- Weight loss surgery, Bariatric surgery, Gut Microbiome, Blood Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WLS non-completers | – | –Participants who did not have WLS as part of the main study |
| WLS completers | – | –Participants who had WLS as part of the main study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gut Microbial Composition
Time frame: 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.
Blood Microbial Composition
Time frame: 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 Weight (kg)
Time frame: Baseline
Body weight will be measured with a calibrated SECA scale.
Body Height (meters)
Time frame: Baseline
Body height will be measured with a stadiometer.
Fat Mass (Kg)
Time frame: Baseline
Body fat mass will be measured by using the SECA mBCA 515.
Fat-free Mass (Kg)
Time frame: Baseline
Fat-free mass will be measured by using the SECA mBCA 515.
Body water (%)
Time frame: Baseline
Body water percentage will be measured by using the SECA mBCA 515.
Skeletal Muscle Mass (kg)
Time frame: Baseline
Skeletal muscle mass will be measured by using the SECA mBCA 515.
Fasting Glucose (mg/dL)
Time frame: Baseline
Fasting glucose will be measured after a 12h fast.
Fasting Insulin (mIU/L)
Time frame: Baseline
Fasting insulin will be measured after a 12h fast.
Lipopolysaccharides (%)
Time frame: Baseline
Lipopolysaccharides will be measured after a 12h fast.
Lipopolysaccharides binding protein (mIU/L)
Time frame: Baseline
Lipopolysaccharides binding protein will be measured after a 12h fast.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benjamin Schneider, M.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Metabolic Syndrome, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gut Microbial Composition (time frame: Stool samples will be collected at one time point only, within a week to their in person appointment.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.