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临床试验/NCT00967122
NCT00967122已完成1 期

The Effect of Lap Band Adjustment on Satiety Peptides

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2009年7月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
15
试验地点
1
主要终点
plasma concentrations of representative hormones of hunger and satiety

研究概览

简要总结

AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.

详细描述

AIMS: Our aims are to measure BMI and plasma concentrations of representative hormones before and after a band holiday, in addition to surveying hunger/satiety and behavior changes.

Materials and Methods

Adults ≥ 18 years of age who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate. Patients of both genders and all races are eligible for participation. Patients will need to consent to complete a questionnaire and to have blood drawn when the band is loosened and refilled. Patients will only be excluded if they are not willing to have their band loosened or if they will not present for follow-up.

Sample size:

For this pilot program we plan to enroll 15 patients. Since patients will serve as their own controls before and after meals as well as before and after band adjustments, we anticipate adequate power to assess for significant variations.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

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

  • Adults ≥ 18 years of age
  • who previously underwent LAGB at New York University Medical Center and have lost sufficient excess body weight and
  • agree to have their band temporarily loosened for a 2 week period will be invited by the health care provider to participate.

排除标准

  • < %35 Excess weight loss

结局指标

主要结局

plasma concentrations of representative hormones of hunger and satiety

时间窗: 2 weeks

次要结局

  • surveying hunger/satiety and behavior changes.(2 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Heekoung A Youn

Research coordinator

NYU Langone Health

研究点 (1)

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