跳至主要内容
临床试验/NCT03195712
NCT03195712已完成不适用

Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers in Class II and III Obesity

St. Luke's-Roosevelt Hospital Center1 个研究点 分布在 1 个国家目标入组 691 人开始时间: 2012年9月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
691
试验地点
1
主要终点
The association between BMI from 35 - 69.9 and Total cholesterol

研究概览

简要总结

The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The study team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.

详细描述

A positive association between BMI and metabolic health risk is often presented graphically as a J-shaped curve with BMI on the x-axis and the biomarker of interest on the y-axis. However, BMI is frequently presented in the literature with a cut point of 35 on the x-axis, leading to the assumption that the steep association continues beyond a BMI of 35. This presentation does not capture the metabolically healthy individual with obesity.

In the population of men and women with class II and II obesity who the clinical team studied, it was examined that the association between BMI as a continuous variable from 35 to 69.9 and metabolic syndrome biomarkers (total-, low density, and high density cholesterol, triglycerides, systolic and diastolic blood pressure, fasting blood glucose, and glycosylated hemoglobin), the study team found no evidence for a positive correlation between BMI and TC, LDL-C, TG, and FBG. And while the study team did find positive and significant correlations between BMI and HDL-C, SBP, DBP, and HgbA1C, the effect sizes were small and arguably clinically insignificant.

The study team's research fills the gap in the obesity literature where BMI with a cut point of 35 is frequently used to show the association between BMI and metabolic syndrome biomarkers. The clinical team was unable to locate any papers that showed the association between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as this clinical team has presented.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
25 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI in the range of 35 - 69.9
  • Men and Women over age 25

排除标准

  • 未提供

结局指标

主要结局

The association between BMI from 35 - 69.9 and Total cholesterol

时间窗: 7 years

The statistical association between a range of BMIs from 35 to 69.9 kg/m2 and total cholesterol reported in mg/dl. Blood draw was performed at an independent lab as prescribed by the patients' private physician and reported to the weight loss program at Mount Sinai St. Luke's Hospital prior to the patient starting the program. To determine the association between the BMIs and total cholesterol a linear regression analysis was performed and reported graphically. The regression equation, R2, and the p-value for the regression were presented on the graph.

次要结局

  • The association between BMI from 35 - 69.9 and Fasting blood glucose(7 years)
  • The association between BMI from 35 - 69.9 and LDL- cholesterol(7 years)
  • The association between BMI from 35 - 69.9 and Diastolic Blood Pressure(7 years)
  • The association between BMI from 35 - 69.9 and HDL- cholesterol(7 years)
  • The association between BMI from 35 - 69.9 and Triglycerides(7 years)
  • The association between BMI from 35 - 69.9 and Systolic Blood Pressure(7 years)
  • The association between BMI from 35 - 69.9 and Hemoglobin A1C(7 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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