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Changes in Ectopic Fat Following Surgically Induced Weight Loss

2017年11月17日更新者：Ildiko Lingvay、University of Texas Southwestern Medical Center

Changes in Ectopic Fat Following Surgically Induced Weight Loss: Does it Explain the Resolution of Diabetes?

This study evaluates how ectopic fat (in the pancreas, heart, liver and skeletal muscle), visceral fat, and subcutaneous fat changes following surgically induced weight loss using gastric banding. The investigators also evaluate whether changes in pancreatic fat content correlate with improvement in beta-cell function.

研究概览

地位

完全的

条件

详细说明

We are looking for volunteers for this study,wich involves 7 visits over a period of 13 months, the first visit taking place about 2 weeks prior to the planned surgery.

Visit 1 - baseline, before starting your pre-operative diet Visit 2 - just before the surgery Visit 3 - around the time your first band inflation occurs Visit 4 - 1 month after the band inflation Visit 5 - 3 months after the first band inflation Visit 6 - 6 months after the first band inflation Visit 7 - 12 months after the first band inflation

At each visit we do the following tests:

MRS to measure your fat in the liver, pancreas, heart, muscle (leg), subcutaneous fat and visceral fat.
Frequently sampled intravenous glucose tolerance test - it is a 3.5 hrs test which determines the amount of insulin your body produces and how well your own insulin is being used by the body
Body measurements (waist, hip circumference), cholesterol panel, liver function tests, HbA1c (to monitor diabetes control), blood pressure, weight.

We also do an oral glucose tolerance test to check for diabetes on 3 occasions: visit 1, visit 5 and at the end, visit 7.

研究类型

观察性的

注册 (实际的)

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

美国
- Texas
  - Dallas、Texas、美国、75390
    - University of Texas Southwestern

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

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients already scheduled to undergo gastric banding within 1-2 months.

This study does NOT pay for the bariatric surgery, eligible participants must already be scheduled to have the surgery performed by their own physician

描述

Inclusion Criteria:

Greater than 18 years old
Fully understanding and willing to undergo study procedures
Available for follow-up
Understand and willing to sign informed consent
Pharmacologic agents with the potential to change ectopic fat content (i.e. pioglitazone) are allowed if the patient has been on a stable dose for at least 3 months and plans to continue the same dose for the duration of the study

Exclusion Criteria:

Contraindication to MRI (i.e. metallic implants, severe claustrophobia, weight above 320lb)
Contraindication to phlebotomy (i.e. no accessible veins, hemoglobin <10 mg/dL)
History of pancreatic disease other than diabetes
Regular use of more than 2 alcoholic drinks per day
Pregnancy
Non-English speaking

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

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Pancreatic and Liver Triglyceride (Fat) Content 大体时间：months after the first band inflation	Pancreatic triglyceride (fat) content measured by the magnetic resonance spectroscopy (MRS) technique in volunteers with a wide range of body mass index (BMI).	months after the first band inflation

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。

赞助

University of Texas Southwestern Medical Center

合作者

National Institutes of Health (NIH)

调查人员

首席研究员：Ildiko Lingvay, MD, MPH、University of Texas Southwestern Medical Center

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

2008年8月1日

初级完成 (实际的)

2012年12月1日

研究完成 (实际的)

2012年12月1日

研究注册日期

首次提交

2009年2月6日

首先提交符合 QC 标准的

2009年2月9日

首次发布 (估计)

2009年2月10日

研究记录更新

最后更新发布 (实际的)

2017年12月13日

上次提交的符合 QC 标准的更新

2017年11月17日

最后验证

2017年11月1日

Changes in Ectopic Fat Following Surgically Induced Weight Loss