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临床试验/NCT05408728
NCT05408728Enrolling By Invitation不适用

Dietary Sugar Hyper-absorptive Intestinal Phenotype as a Predictor of Weight Loss Post-bariatric Surgery

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2022年7月10日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
Mayo Clinic
入组人数
52
试验地点
1
主要终点
Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery

研究概览

简要总结

This study is trying to determine whether the success of bariatric surgery can be predicted by evaluating the dietary sugar absorptive characteristics in the small intestine and if there is any gene expression change on the dietary sugar absorptive characteristics.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Obese patients (BMI ≥ 30) scheduled for BS undergoing standard of care screening EGD, or lean BS-naïve individuals (BMI ≤ 25) subjected to EGD for routine clinical indications as part of standard care.

排除标准

  • Adults unable to consent, including non-English speakers.
  • Pregnant women because endoscopy is a risk factor. All patients of childbearing age undergo history as well as urine pregnancy test as a standard of care prior to undergoing endoscopy as the procedure is performed under anesthesia.
  • Prisoners.
  • Subjects with preexisting conditions (e.g., bleeding at the time of the procedure, suspected perforation during the standard-of-care procedure) will be excluded from the study at the time of the endoscopy.
  • Have a contraindication to endoscopy.
  • A history of surgery on the stomach or small intestine.
  • Type 1 diabetes (clinical diagnosis and/or positive glutamic acid decarboxylase antibodies).
  • Using weight loss medications.
  • Active malignancy within the last 5 years.

结局指标

主要结局

Number of obese patients with altered dietary sugar hyper-absorptive phenotype after bariatric surgery

时间窗: 18 months

次要结局

  • Epigenetic changes measured in the intestinal mucosa of obese patients with dietary sugar hyper-absorptive phenotype after bariatric surgery(18 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dilhana S. Badurdeen

Principal Investigator

Mayo Clinic

研究点 (1)

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