Socioecological Factors Associated With Ethnic Disparities in Bariatric Surgery Utilization and Post-Operative Weight Loss (Substudy)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Gut Microbial Composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Gut Microbial Composition
时间窗: 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)
时间窗: Baseline
Fasting glucose will be measured after a 12h fast.
Blood Microbial Composition
时间窗: 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)
时间窗: Baseline
Body height will be measured with a stadiometer.
Fat Mass (Kg)
时间窗: Baseline
Body fat mass will be measured by using the SECA mBCA 515.
Skeletal Muscle Mass (kg)
时间窗: Baseline
Skeletal muscle mass will be measured by using the SECA mBCA 515.
Fasting Insulin (mIU/L)
时间窗: Baseline
Fasting insulin will be measured after a 12h fast.
Lipopolysaccharides binding protein (mIU/L)
时间窗: Baseline
Lipopolysaccharides binding protein will be measured after a 12h fast.
Body water (%)
时间窗: Baseline
Body water percentage will be measured by using the SECA mBCA 515.
Lipopolysaccharides (%)
时间窗: Baseline
Lipopolysaccharides will be measured after a 12h fast.
Body Weight (kg)
时间窗: Baseline
Body weight will be measured with a calibrated SECA scale.
Fat-free Mass (Kg)
时间窗: Baseline
Fat-free mass will be measured by using the SECA mBCA 515.
次要结局
未报告次要终点
研究者
Benjamin Schneider
Associate Professor & Division Chief - Bariatric & Foregut Surgery
University of Texas Southwestern Medical Center