Progressive Weight Loss and Metabolic Health (PWL)
2017年6月30日 更新者：Washington University School of Medicine
This study will evaluate the potential beneficial cardiometabolic effect of moderate (5%) weight loss and progressive (5%, 10%, and 15%) weight loss in obese adults without diabetes.
Participants will be randomly assigned to one of 2 groups.
Group 1: supervised weight loss group (low-calorie diet).
Group 2: supervised weight maintenance group (normal diet).
Of those assigned to group 1, half of the participants will lose 5% of their body weight and the other half will lose 5%, 10%, and 15% of their weight over time under the guidance of a dietitian.
Research testing will be repeated at each time point (5%, 10%, and 15% weight loss).
In group 2, research testing will be repeated after six months.
研究概览
研究类型
介入性
注册 (实际的)
59
阶段
- 不适用
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
-
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine
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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
21年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Obese: Body Mass Index from 30 to 45
- Insulin Resistant: HOMA-IR score greater than or equal to 2
Exclusion Criteria:
- diabetes
- smoking
- pregnancy
- breastfeeding
- heart failure
- history of liver disease including hepatitis
- alcoholism
- exercise more than 2 hours per week
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
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Weight Loss
Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.
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Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.
|
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有源比较器：Weight Maintenance
Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.
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Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.
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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 |
|---|---|---|
|
Insulin Sensitivity
大体时间：baseline through weight loss (approximately one year)
|
In the weight-loss arm we will measure insulin sensitivity at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure insulin sensitivity at baseline and after six months.
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baseline through weight loss (approximately one year)
|
|
intra-hepatic triglyceride
大体时间：baseline through weight loss (approximately one year)
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In the weight-loss arm we will measure intra-hepatic triglyceride at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure intra-hepatic triglyceride at baseline and after six months.
|
baseline through weight loss (approximately one year)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
total cholesterol
大体时间：baseline through weight loss (approximately one year)
|
In the weight-loss arm we will measure total cholesterol at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure total cholesterol at baseline and after six months.
|
baseline through weight loss (approximately one year)
|
|
systolic blood pressure
大体时间：baseline through weight loss (approximately one year)
|
In the weight-loss arm we will measure systolic blood pressure at baseline, after 5% weight loss, after 10% weight loss and again after 15% weight loss.
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure systolic blood pressure at baseline and after six months.
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baseline through weight loss (approximately one year)
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Cell proliferation (growth) rates in the colon - optional procedure
大体时间：baseline through weight loss (approximately four months to one year)
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Colon cell proliferation rates will be determined using stable isotope labelled tracer methods in conjunction with sigmoid colon biopsy samples.
In the weight-loss arm we will measure colonocyte proliferation rate at baseline, and once again after weight loss (either 5% weight loss, or 10% weight loss, or 15% weight loss; i.e.
only one time after weight loss).
Each weight loss phase will last an average of four months for a total of approximately one year.
In the weight maintenance arm we will measure colonocyte proliferation rate at baseline and after six months.
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baseline through weight loss (approximately four months to one year)
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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。
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。
一般刊物
- Yoshino J, Patterson BW, Klein S. Adipose Tissue CTGF Expression is Associated with Adiposity and Insulin Resistance in Humans. Obesity (Silver Spring). 2019 Jun;27(6):957-962. doi: 10.1002/oby.22463. Epub 2019 Apr 19.
- Volkow ND, Wang GJ, Telang F, Fowler JS, Goldstein RZ, Alia-Klein N, Logan J, Wong C, Thanos PK, Ma Y, Pradhan K. Inverse association between BMI and prefrontal metabolic activity in healthy adults. Obesity (Silver Spring). 2009 Jan;17(1):60-5. doi: 10.1038/oby.2008.469. Epub 2008 Oct 23.
- van Vliet S, Koh HE, Patterson BW, Yoshino M, LaForest R, Gropler RJ, Klein S, Mittendorfer B. Obesity Is Associated With Increased Basal and Postprandial beta-Cell Insulin Secretion Even in the Absence of Insulin Resistance. Diabetes. 2020 Oct;69(10):2112-2119. doi: 10.2337/db20-0377. Epub 2020 Jul 10.
- de Jonge L, Moreira EA, Martin CK, Ravussin E; Pennington CALERIE Team. Impact of 6-month caloric restriction on autonomic nervous system activity in healthy, overweight, individuals. Obesity (Silver Spring). 2010 Feb;18(2):414-6. doi: 10.1038/oby.2009.408. Epub 2009 Nov 12.
- McLaughlin T, Abbasi F, Kim HS, Lamendola C, Schaaf P, Reaven G. Relationship between insulin resistance, weight loss, and coronary heart disease risk in healthy, obese women. Metabolism. 2001 Jul;50(7):795-800. doi: 10.1053/meta.2001.24210.
- Chondronikola M, Magkos F, Yoshino J, Okunade AL, Patterson BW, Muehlbauer MJ, Newgard CB, Klein S. Effect of Progressive Weight Loss on Lactate Metabolism: A Randomized Controlled Trial. Obesity (Silver Spring). 2018 Apr;26(4):683-688. doi: 10.1002/oby.22129. Epub 2018 Feb 24.
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
2011年2月1日
初级完成 (实际的)
2015年9月1日
研究完成 (实际的)
2016年4月1日
研究注册日期
首次提交
2011年2月10日
首先提交符合 QC 标准的
2011年2月17日
首次发布 (估计)
2011年2月18日
研究记录更新
最后更新发布 (实际的)
2017年7月5日
上次提交的符合 QC 标准的更新
2017年6月30日
最后验证
2017年6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.