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Bariatric Surgery Outcomes

2014年12月5日 更新者:University of California, Los Angeles

Bariatric Surgery Outcomes: Quality of Life / Reproductive-Age Women

The UCLA Metabolic and Bariatric Surgery Program (adult program) and the UCLA Fit for Healthy Weight Program (adolescent program) are committed to the care of morbidly obese patients. This study is observational. The investigators plan to evaluate bariatric surgery outcomes using the BAROS National Database and also to evaluate quality of life pre- and post bariatric surgery. In addition, the investigators plan to enroll a subgroup of 10 reproductive-age women to evaluate: 1) pregnancy and offspring health, 2) long-term nutrition, 3) biomarkers/epigenome, and 4) body-composition/bone-density.

研究概览

地位

撤销

条件

详细说明

  1. National Database: The purpose of the Bariatric Outcomes Longitudinal Database (BOLD) study is to study the mid- and long-term outcomes of bariatric surgeries and to analyze the relationship between these outcomes and 1) patient demographics and comorbidities, 2) clinical and surgical characteristics, and 3) pre-operative, peri-operative, and post-operative care and treatment. The UCLA program will be just one of many institutions that participate in the BOLD study. Participants include other programs and surgeons who have received a Full Approval or Provisional Status designation in the American Society for Bariatric Surgery (ASBS) Bariatric Surgery Center for Excellence program. This study, along with the database itself, is being established, maintained and overseen by East Carolina University in association with the Surgical Review Corporation.
  2. Health Survey: The purpose of evaluating physical and mental health is to document changes that occur following surgery. Standardized surveys will include SF-36, (Bariatric Analysis and Reporting Outcome System), BAROS, and Epworth Sleepiness Scale. Our hypothesis is that bariatric surgery will improve quality of life for the majority of patients.
  3. Reproductive-Age Women:

While the number of bariatric procedures performed has increased to over 200,000 annually, this number represents only a small fraction of those that qualify. The prevalence of extreme obesity is higher in women than in men (7% vs. 3%), and women are disproportionately more likely to undergo bariatric surgery. Nearly 80% of patients undergoing bariatric surgery are female and 35% are less than 40 years of age.

Given the current demographics of metabolic/bariatric surgery and the epidemic of childhood obesity, it is important to evaluate the long-term impact of bariatric surgery on nutrition, pregnancy, offspring health, and bone density. Despite previous concerns, metabolic/bariatric surgery has been demonstrated to improve maternal outcomes and likely improves neonatal outcomes. Interestingly, weight-loss surgery has been demonstrated to reduce the incidence of obesity in offspring by 50%. It is unclear whether improvements in offspring health are related to changes in the uterine environment, the post-natal environment, or the epigenome.

While obesity has been associated with Vitamin D deficiency and hyperparathyroidism, it is not usually associated with the development of osteoporosis. Bariatric surgery can impair calcium absorption and exacerbate vitamin deficiencies. However, the impact of surgery on bone mineral content and density is unclear. This has particular ramifications for young female patients and the risk of osteoporosis long-term.

The purpose is this portion of the study is to evaluate the impact of metabolic/bariatric surgery on reproductive-age women (age 13 to 30) with respect to weight, nutritional status, body composition, biomarker/epigenome profile, markers of atherosclerosis, and bone mineral content/density.

  1. Obstetrical/Offspring Health and Fertility: The purpose of this assessment is to evaluate the impact of surgery on obstetrical complications, offspring health, and fertility. A simple questionnaire will be administered to women of reproductive age.
  2. Biomarkers /Epigenetic Markers: The purpose of collecting specimens (e.g. blood) and analyzing changes in hormones, biologic markers, and epigenetic markers is to help elucidate potential mechanism involved in weight loss.
  3. Imaging: In collaboration with Children's Hospital - Los Angeles, we will coordinate imaging to evaluate body composition, bone density/content, and subclinical markers of atherosclerosis. Imaging studies will include DEXA (dual x-ray absorptiometry) for patients under 300 lbs, low-dose CT-scan for patients under 350 lbs, and ultrasound of the vessels of the neck.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Los Angeles、California、美国、90095
        • UCLA
      • Los Angeles、California、美国、90027
        • Children's Hospital - Los Angeles

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients undergoing bariatric surgery.

描述

  1. Bariatric Surgery Patient Cohort:

    Inclusion Criteria:

    • Patients undergoing bariatric surgery.

    Exclusion Criteria:

    • None
  2. Reproductive-Age Women Patient Cohort:

Inclusion Criteria:

  • Patients undergoing bariatric surgery.
  • Age 13-30 females.
  • Weight less than 350lbs (to accommodate imaging).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Bariatric Surgery Patients
Patients undergoing bariatric surgery.
Bariatric Surgery
Reproductive-Age Women - Bariatric Surgery Patients
This subgroup of patients will include 10 reproductive-age women.
Bariatric Surgery

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Quality of Life.
大体时间:up to 5-year.
up to 5-year.
Biomarkers, RNA Expression Profile, Epigenetic Markers
大体时间:up to 5-year
up to 5-year
Bone density/content and body composition.
大体时间:up to 5-year.
up to 5-year.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Daniel DeUgarte, MD、University of California, Los Angeles

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2010年3月1日

初级完成 (实际的)

2014年7月1日

研究完成 (实际的)

2014年7月1日

研究注册日期

首次提交

2010年1月26日

首先提交符合 QC 标准的

2010年1月26日

首次发布 (估计)

2010年1月27日

研究记录更新

最后更新发布 (估计)

2014年12月8日

上次提交的符合 QC 标准的更新

2014年12月5日

最后验证

2010年1月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

Bariatric surgery.的临床试验

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