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临床试验/NCT03915158
NCT03915158Unknown不适用

Biochemical Evaluations of Nutritional Status of Patients Before and After Bariatric and Metabolic Surgery

China Medical University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Change of Nutritional status

研究概览

简要总结

This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the sleeve gastrectomy operation.

详细描述

Bariatric surgery (BS) is the most effective treatment for severe obesity and comorbidities. Among varieties of BS techniques, sleeve gastrectomy (SG) has gained in popularity worldwide. SG is a procedure involved mainly restriction combined slightly with malabsorption (deficiency in intrinsic factors for vitamin B12 absorption). Considering most patients usually have more than one micronutrients deficiency prior the surgery, the aggravated nutritional status is one of post-surgical concerns. For nutrition management, individualized biochemical assessment for micronutrients is highly recommended in guideline, but is seldom been implanted. Instead, a routine supplementation for vitamins/minerals for postoperative patients is practiced in Taiwan. This study aimed at evaluating the nutritional status of vitB1, B2, B12, folate, A, D, E, Ca, Fe, Zn, Cu, and Se prior- and post- (6-Mo) the SG operation. Subjects (n=70-100) will be recruited from patients of Body Science & Metabolic Disorders, International BMI Medical Center of CMUH. The inclusion criteria are Han Chinese, 18-65 years old, and BMI>30 who have arranged for SG operation. Written informed consent will be obtained from participants. Anthropometric data, blood samples, food (including supplements) records and medical history will be collected during the study period. We foresee this study may, not only achieve a personalized dietary plan, but also contribute to indigenous data regarding micronutrient status of obese patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Han Chinese and Taiwanese
  • BMI more than or equal to 27.5
  • Surgery type is sleeve gastrectomy

排除标准

  • Kidney dysfunction
  • Mental illness
  • Severe eating disorders
  • Alcohol or drug abuse
  • Stomach ulcers
  • Redo bariatric surgery

结局指标

主要结局

Change of Nutritional status

时间窗: pre-surgery and 6 months after surgery

Blood sample will be collected and used to determine nutritional status which will measured by laboratory biochemical test.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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