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| ID | Type | Description | Link |
|---|---|---|---|
| R01MD011686 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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:
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.
Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
| Body Weight (kg) | Body weight will be measured with a calibrated SECA scale. | Baseline |
| Body Height (meters) | Body height will be measured with a stadiometer. | Baseline |
| Fat Mass (Kg) | Body fat mass will be measured by using the SECA mBCA 515. | Baseline |
| Fat-free Mass (Kg) | Fat-free mass will be measured by using the SECA mBCA 515. | Baseline |
| Body water (%) | Body water percentage will be measured by using the SECA mBCA 515. | Baseline |
| Skeletal Muscle Mass (kg) |
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Inclusion Criteria:
Exclusion Criteria:
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Investigators will recruit in the following manner:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Schneider, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 19, 2024 | Mar 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2024 | Mar 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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2 blood sample tubes collected at the same timepoint and 1 stool sample
Skeletal muscle mass will be measured by using the SECA mBCA 515. |
| Baseline |
| Fasting Glucose (mg/dL) | Fasting glucose will be measured after a 12h fast. | Baseline |
| Fasting Insulin (mIU/L) | Fasting insulin will be measured after a 12h fast. | Baseline |
| Lipopolysaccharides (%) | Lipopolysaccharides will be measured after a 12h fast. | Baseline |
| Lipopolysaccharides binding protein (mIU/L) | Lipopolysaccharides binding protein will be measured after a 12h fast. | Baseline |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |