Physiological Effects of ANGPTL3 Variants in Humans

Not Applicable

Recruiting

• Conditions: Hypocholesterolemia
• Interventions: Other: Kinetics test, oral fat tolerance test, and an oral glucose tolerance test.

• Registration Number: NCT04234724
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2020-01-15
• Study First Posted: 2020-01-21
• Study Start: 2020-12-01
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Subjects aged 18 or older meeting at least one of the following criteria

  1. Carrying genetic variants in the gene encoding for ANGPTL3,
  2. Unaffected controls matched for age, race, gender,
  3. Willing to follow study procedures
  4. Able to provide inform consent

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Variant	Kinetics test, oral fat tolerance test, and an oral glucose tolerance test.	Volunteers with known ANGPTL3 variants
Non-variant	Kinetics test, oral fat tolerance test, and an oral glucose tolerance test.	Healthy volunteers with no ANGPTL3 variants

Primary Outcome Measures

Name	Time	Method
The role of ANGPTL3 on lipid metabolism.	through study completion, an average of 13 weeks	Assessing ApoB-containing lipoprotein fractional catabolic rate
The role of this protein on glucose metabolism.	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	through study completion, an average of 13 weeks	Looking for fatty acids area under the curve following Oral Fat Tolerance Test

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States