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临床试验/NCT05008952
NCT05008952已完成不适用

Postprandial Triglycerides, Endothelial Function, and Inflammatory Cytokines as Potential Candidates for Early Risk Detection in Normal-weight Obesity

Oklahoma State University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
4-hour triglycerides after fat tolerance test

研究概览

简要总结

The purpose of this study is to identify early cardiovascular disease risk factors in those with "normal-weight obesity" (i.e., normal body, but high body fat percentage) that better track with their long-term cardiovascular disease risk.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Control group: normal BMI, body fat percentage < 25% for men and 35% for women
  • •Normal-weight obesity group: normal BMI, body fat percentage > 25% for men and 35% for women
  • •Metabolic syndrome group: BMI > 30 and 2 or more of the following: blood pressure >130/85 mmHg, fasting glucose >100 mg/dL, fasting triglycerides >150 mg/dL, HDL cholesterol < 40 mg/dL (men) or < 50 mg/dL (women).

排除标准

  • •Presence of pacemaker
  • •use of tobacco products
  • •using lipid lowering drugs

研究组 & 干预措施

Control group

Active Comparator

The control group for this study will consist of individuals with normal BMI (18.5 - 24.9 kg/m2), body fat percent < 25% (male) or < 35% (female), and up to 1 other risk factor among the following: blood pressure > 130/85 mmHg, fasting glucose >100 mg/dL, fasting triglycerides >150 mg/dL, and HDL < 40 (male) or < 50 (female).

干预措施: High-fat shake (Other)

Normal-weight obesity

Experimental

Individuals with normal-weight obesity will be defined as having normal BMI (18.5 - 24.9 kg/m2), body fat percent > 25% (male) or > 35% (female).

干预措施: High-fat shake (Other)

Metabolic Syndrome

Active Comparator

Metabolic syndrome will be defined using the international Diabetes Federation criteria of an obese BMI ( > 30 kg/m2) and 2 or more of the following risk factors: blood pressure > 130/85 mmHg, fasting glucose >100 mg/dL, fasting triglycerides >150 mg/dL, and HDL < 40 (male) or < 50 (female).

干预措施: High-fat shake (Other)

结局指标

主要结局

4-hour triglycerides after fat tolerance test

时间窗: Within 2 weeks of study enrollment

Participants will undergo an abbreviated fat tolerance test, where fasting triglycerides are measured, a high-fat shake is consumed, and triglycerides measured once more 4 hours later. 4 hour triglycerides after the high-fat meal is our primary outcome.

次要结局

  • Flow-mediated dilation(Within 2 weeks of study enrollment)
  • Fasting serum cytokines(Within 10 months of study enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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