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Metabolism of Fibrinogen and Apolipoprotein B-100 in Childhood Obesity and Cardiovascular Disease

2022年10月13日 更新者:Babu Balagopal、Nemours Children's Clinic

Since obesity and plasma fibrinogen levels are important CVD risk factors in the adults, and since childhood obesity is a major risk factor for adult obesity and also because it is not established whether or not this is due to an increase in the FSR of fibrinogen, the investigators set up the studies with the following specific aims:

  1. To investigate the metabolism of fibrinogen and VLDL apoB-100, CVD risk factors, in childhood obesity by measuring their fractional synthetic rate (FSR) compared to lean age and sex matched controls
  2. To determine the outcome of a three month non-pharmacological intervention (physical exercise combined with controlled diet) to reduce weight on the FSR of fibrinogen and apoB-100
  3. To determine the relationship between FSR of fibrinogen and IL-6 in obese children and its potential implications on CVD before and after the non-pharmacological intervention
  4. To determine other CVD risk factors, PAI-1 levels, D-Dimer concentration, homocysteine, insulin, free fatty acid, HDL & LDL cholesterol and blood pressure in response to weight reduction (as consequence of a combined program of diet and exercise).

研究概览

详细说明

A. SPECIFIC AIMS:

Evidence from the literature suggests that:

  1. childhood onset of obesity increases the risk of obesity and cardiovascular disease (CVD) in adulthood;
  2. plasma fibrinogen and apolipoprotein B-100 (apoB-100) levels are elevated in obesity;
  3. elevated levels of plasma fibrinogen and apolipoprotein B-100 (apoB-100) are major independent risk factors for CVD in adults;
  4. raised plasma fibrinogen levels in obese children and/adolescents could be a major factor responsible for CVD morbidity and mortality in adulthood;
  5. a low level of physical activity is associated with a high level of plasma fibrinogen in adults;
  6. physical training and controlled diet have been proved to be non-pharmacological ways to improve hemostatic function in adults, thereby reducing heart disease risk. Despite these evidences the mechanism of these changes remain unclear. A better understanding of the mechanism of these changes will lead to more directed therapies to reduce these risk factors early in life.

The increased plasma concentrations of fibrinogen (and/or other proteins) is decided by the equilibrium between two dynamic processes in the body, namely, synthesis and degradation rates of these proteins. Therefore, elevated levels of fibrinogen must be a consequence of:

  1. increased fibrinogen synthesis;
  2. decreased fibrinogen degradation or
  3. a contribution of both.

For designing effective therapies it is important to know, whether the increased concentration of plasma fibrinogen is due to increased synthesis or decreased degradation or both. Using stable isotope mass spectrometry techniques it is possible to measure the synthesis rates of proteins in vivo in humans. Yet until now there are no reports on the direct measurement of FSR of fibrinogen and/or apoB-100 in childhood obesity, important CVD risk factors. The direct measurement of degradation rates of proteins in vivo in humans, however, is not easily done. Few studies have reported changes in the concentrations of fibrinolytic markers such as plasminogen activator inhibitor-1 (PAI-1) and D-Dimer in obesity. This, however, accounts for only a small fraction of the elevated levels of plasma fibrinogen in childhood obesity. On the other hand recent preliminary results in three subjects from our lab show that fibrinogen synthesis rate is substantially higher (more than two times) in obese adolescent girls Vs lean controls (please see results under "Preliminary results" below). Pro-inflammatory cytokines, particularly interleukin-6 (IL-6), are known to play an important role in the regulation of acute phase reactive proteins associated with inflammation, including fibrinogen. A direct link between IL-6 and increased FSR of plasma fibrinogen in childhood obesity and CVD, however, is unknown. Also, other mechanisms involving insulin resistance and free fatty acid/albumin ratio are also equally plausible for the increased synthesis of fibrinogen in obesity and CVD. Therefore, it is important to understand and establish the relationship between increased FSR of fibrinogen and these regulating factors in this study for two reasons:

  1. to better design effective therapies based on these results and
  2. to further understand the pathophysiology of these changes in CVD and obesity.

The overall purpose of the proposed studies is therefore:

  1. to expand on our preliminary data and establish the observation of increased fibrinogen synthesis rate (in three subjects) in childhood obesity
  2. to understand the relationship between increased FSR of fibrinogen and changes IL-6, insulin and glucose levels and free fatty acid (FFA) levels and FFA/albumin ratio in obese vs lean children
  3. to study the effect of a non-pharmacological intervention program for three months (12 weeks), that involves weight reduction due to exercise and controlled diet on fibrinogen, apoB-100 and other cardiovascular risk factors and their relationship to changes in IL-6 levels, insulin/glucose ratio (a measure of insulin resistance), FFA/albumin ratio.

The proposed grant will use in vivo stable isotope (non-radioactive) dilution techniques, to test the following hypothesis:

Hypotheses:

  1. higher rates of synthesis of fibrinogen and apoB-100 contribute substantially to their elevated levels in obese children;
  2. plasma fibrinogen and apoB-100 concentration and synthesis decrease by non-pharmacological intervention to reduce weight, that involves regular physical exercise and controlled diet;
  3. IL-6 and/or insulin resistance are important mechanistic links between increased plasma fibrinogen FSR and increased CVD risk and obesity and
  4. the non-pharmacological intervention program modulates other CVD risk factors such as PAI-1, D-Dimer, homocysteine, free fatty acids, insulin, glucose, HDL and LDL cholesterol levels and IL-6 concentrations along with fibrinogen synthesis.

Summary of Specific Aims

Since obesity and plasma fibrinogen levels are important CVD risk factors in the adults, and since childhood obesity is a major risk factor for adult obesity and also because it is not established whether or not this is due to an increase in the FSR of fibrinogen, the investigators set up the studies with the following specific aims:

  1. To investigate the metabolism of fibrinogen and VLDL apoB-100, CVD risk factors, in childhood obesity by measuring their fractional synthetic rate (FSR) compared to lean age and sex matched controls
  2. To determine the outcome of a three month non-pharmacological intervention (physical exercise combined with controlled diet) to reduce weight on the FSR of fibrinogen and apoB-100
  3. To determine the relationship between FSR of fibrinogen and IL-6 in obese children and its potential implications on CVD before and after the non-pharmacological intervention
  4. To determine other CVD risk factors, PAI-1 levels, D-Dimer concentration, homocysteine, insulin, free fatty acid, HDL & LDL cholesterol and blood pressure in response to weight reduction (as consequence of a combined program of diet and exercise).

研究类型

介入性

注册 (实际的)

21

阶段

  • 不适用

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

14年 至 18年 (孩子、成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Obese: BMI ≥30 kg/m2
  • Lean (controls): BMI ≤ 25 kg/m2) age 14 to 18 years and Tanner stage matched
  • Ability to understand and cooperate with the procedures
  • Signed informed consent from subjects and parents

Exclusion Criteria:

  • Medications such as Beta-adrenergic blockers, steroids and other drugs known to affect protein metabolism
  • Heart disease
  • Chronic liver disease
  • Chronic renal disease
  • Active malignancy
  • Alcoholism or drug abuse
  • Anemia
  • Inter-current illness over the 7 days before the study
  • Surgery in the past 3 months

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:预防
  • 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:Intervention
12 weeks of lifestyle-based physical activity intervention
Obese subjects will undergo a randomized physical activity-based weight reduction program (12 weeks). The lifestyle intervention will be determined based on an initial evaluation of each subjects' energy expenditure (by indirect calorimetry). Caloric intake will be set to elicit the loss of 1 to 1.5 lbs/week. The subjects and the family will meet with a dietitian once/week for 12 weeks. The intervention group will undergo an aerobic exercise program 3 times/week. The duration of exercise will be progressively increased from 20 to 45 minutes/session. The subjects will keep daily record of exercise activity and food intake. Interventions will be monitored during the subjects' weekly visit with the research group and they will be given counseling to stick to the intervention program.
无干预:Control
12 weeks of no intervention

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
Protein turnover
大体时间:12 weeks
Stable isotope mass spectrometry
12 weeks
Fractional synthesis rate of fibrinogen
大体时间:12 weeks
Stable isotope mass spectrometry
12 weeks
Fibrinogen
大体时间:12 weeks
Plasma concentration measured by nephelometry
12 weeks

次要结果测量

结果测量
措施说明
大体时间
Fat mass
大体时间:12 weeks
Dual-energy X-ray absorptiometry (DEXA)
12 weeks
Fat free mass
大体时间:12 weeks
Dual-energy X-ray absorptiometry (DEXA)
12 weeks

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:Babu Balagopal, PhD、Nemours Children's Clinic

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

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 (实际的)

2001年1月1日

初级完成 (实际的)

2004年1月1日

研究完成 (实际的)

2020年12月1日

研究注册日期

首次提交

2015年11月19日

首先提交符合 QC 标准的

2015年11月23日

首次发布 (估计)

2015年11月24日

研究记录更新

最后更新发布 (实际的)

2022年10月14日

上次提交的符合 QC 标准的更新

2022年10月13日

最后验证

2022年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • C.20.8840
  • 0030342B (其他赠款/资助编号:American AHeart Association)

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.

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