NCT02654496已完成不适用
The Gut Microbiota in Patients Post Roux-en-Y Gastric Bypass Surgery
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
研究概览
简要总结
The purpose of this study is to investigate mechanisms responsible for weight change in patients who have undergone weight loss surgery. Specifically, we will compare the gut microbiota, plasma bile acids, plasma gut peptides (GLP-1, GLP-2, and PYY), and plasma LPS in three groups of subjects: 3-5 years post gastric bypass patients who experienced sub-optimal weight loss, 3-5 years post gastric bypass patients who had successful weight loss, and a control group who has not had a weight loss surgery and are of similar age, gender, body mass index as the gastric bypass groups.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •3-5 years post Roux-en-Y gastric bypass and experienced successful weight loss following surgery (up to n=10) or
- •3-5 years post Roux-en-Y gastric bypass and did not experience optimal weight loss following surgery (up to n=10) or
- •Nonsurgical control participants who are approximately matched in sex, age, and BMI to the optimal weight loss group (up to n=10).
排除标准
- •Tobacco use in past three months.
- •Taking a medication which is known to significantly influence gastrointestinal transit time or affect the microbiome or other variables significantly (as determined by study pharmacist/MD).
- •History of diabetes mellitus.
- •Has taken an oral or IV/IM antibiotic in the past 3 months.
- •Has taken probiotic and/or prebiotic agent in the past 3 months
- •History of significant intestinal disease or disorder (e.g., Crohn's disease, ulcerative colitis, irritable bowel syndrome)
- •History of gastrointestinal surgery that may impact measures of biological variables, as determined by the investigator.
- •Medical condition expected to impact the biological variables of interest or interfere with providing a sample, as determined by the investigator.
- •Unable to speak/read English.
- •Breastfeeding, pregnant, or planning to become pregnant within the duration of the study.
- •Unwilling to use a medically acceptable form of contraception.
- •History of bipolar or psychotic spectrum disorder or alcohol or substance treatment in the past year
结局指标
主要结局
Intestinal Microbiome Composition. The ratio of firmicutes to bacteroidetes will be the primary focus of the microbiome evaluation.
时间窗: 3-5 years post RYGB
次要结局
- Plasma levels of cholic acid, chenodeoxy cholic acids, deoxycholic acid, and lithocholic acid will be measured by LCMS and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.(3-5 years post RYGB)
- Plasma levels of GLP-1, GLP-2, and PYY will be measured by ELISA and will be compared between successful weight loss and poor weight loss post-RYGB and control groups.(3-5 years post RYGB)
- Plasma levels of Lipopolysaccharide (LPS) will be measured by the Limulus Amebocyte Lysate (LAL) assay and will be compared between successful weight loss and poor weigh loss post-RYGB and control groups.(3-5 years post RYGB)
研究者
Kristine Steffen
Associate Professor
North Dakota State University
研究点 (1)
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