跳至主要内容
临床试验/NCT04234724
NCT04234724招募中不适用

Physiological Effects of ANGPTL3 Variants in Humans

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
The role of ANGPTL3 on lipid metabolism.

研究概览

简要总结

To evaluate the role of ANGPTL3, on lipid metabolism. To explore the role of this protein on glucose metabolism.

详细描述

Oral fast tolerance test, lipoprotein kinetics and a glucose tolerance test to evaluate the role of ANGPTL3, on lipid metabolism and to explore the role of this protein on glucose metabolism.

研究设计

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

入排标准

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

入选标准

  • Subjects aged 18 or older meeting at least one of the following criteria
  • Carrying genetic variants in the gene encoding for ANGPTL3,
  • Unaffected controls matched for age, race, gender,
  • Willing to follow study procedures
  • Able to provide inform consent

排除标准

  • Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
  • Taking any medication that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
  • Women that are pregnant or nursing
  • History of liver disease or abnormal liver function tests (>2x upper limit of normal)
  • History of kidney disease or chronic renal insufficiency (eGFR <60 mL/min/1.73 m2)
  • Uncontrolled hypertension (>160/100 mmHg)
  • Uncontrolled diabetes
  • Anemia (hemoglobin <11.0 mg/dL) History of a non-skin malignancy within the previous 5 years Major surgery within the past 3 months
  • History of any organ transplant
  • History of alcohol or drug abuse
  • Participation in clinical trials assessing the efficacy and safety of drugs affecting lipid metabolism within the past 6 weeks (or longer depending on the known half-life of the drug) that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, or confound the study data
  • Inability to comply to study procedures

结局指标

主要结局

The role of ANGPTL3 on lipid metabolism.

时间窗: through study completion, an average of 13 weeks

Assessing ApoB-containing lipoprotein fractional catabolic rate

The role of this protein on glucose metabolism.

时间窗: through study completion, an average of 13 weeks

Looking for glucose area under the curve following Oral Glucose Tolerance Test

The role of ANPTL3 on fatty acids

时间窗: through study completion, an average of 13 weeks

Looking for fatty acids area under the curve following Oral Fat Tolerance Test

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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