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临床试验/NCT02686905
NCT02686905Unknown不适用

Effects of Vitamin Supplementation on Micronutrient Blood Values, Body Composition, Waist-to-hip Ratio and Fasting Blood Glucose After Bariatric Surgery

California State Polytechnic University, Pomona2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
Vitamin B12 Blood Value

研究概览

简要总结

The objectives in this study are to provide information on the efficacy of transdermal supplement patches on treating nutrient malabsorption and deficiency in post-op bariatric patients, and to determine short-term body composition, HbA1c and fasting plasma glucose outcomes for patients after bariatric surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

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

  • patients currently approved for vertical sleeve or gastric bypass bariatric surgery
  • female patients should not be pregnant or plan to become pregnant

排除标准

  • metal objects in the body
  • current weight greater than 600lbs
  • previous bariatric (revision) surgery

结局指标

主要结局

Vitamin B12 Blood Value

时间窗: 3 months

B12 (pg/mL)

Vitamin D Blood Value

时间窗: 3 months

Vitamin D, 25-Hydroxy (pg/mL)

Fat Free Mass Measurement

时间窗: 3 months

Fat Free Mass (kg) via Tanita scale measurements

Fasting Blood Glucose

时间窗: 3 months

Glucose (mg/dL)

Calcium Blood Value

时间窗: 3 months

Calcium (mg/dL)

Weight Measurement

时间窗: 3 months

Weight (kg) via Tanita scale measurements

Waist Circumference

时间窗: 3 months

Waist circumference (cm)

Hip Circumference

时间窗: 3 months

Hip circumference (cm)

Iron Blood Value

时间窗: 3 months

Ferritin (ng/mL)

HbA1c Blood Value

时间窗: 3 months

Hemoglobin A1c (%)

Fat Mass Measurement

时间窗: 3 months

Fat Mass (kg) via Tanita scale measurements

次要结局

  • Height(3 months)
  • Total Body Water(3 months)

研究者

发起方
California State Polytechnic University, Pomona
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rebecca McDorman

Graduate Student

California State Polytechnic University, Pomona

研究点 (2)

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