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Physiological Effects of ANGPTL3 Variants in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04234724
Recruitment Status : Suspended (Suspended due to COVID-19)
First Posted : January 21, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Pennsylvania

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

Condition or disease Intervention/treatment Phase
Hypocholesterolemia Other: Kinetics test, oral fat tolerance test, and an oral glucose tolerance test. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Physiological Effects of ANGPTL3 Variants in Humans
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Arm Intervention/treatment
Experimental: Variant
Volunteers with known ANGPTL3 variants
Other: Kinetics test, oral fat tolerance test, and an oral glucose tolerance test.
Subjects will participate in a kinetics test, oral fat tolerance test, and an oral glucose tolerance test.

Non-variant
Healthy volunteers with no ANGPTL3 variants
Other: Kinetics test, oral fat tolerance test, and an oral glucose tolerance test.
Subjects will participate in a kinetics test, oral fat tolerance test, and an oral glucose tolerance test.




Primary Outcome Measures :
  1. The role of ANGPTL3 on lipid metabolism. [ Time Frame: through study completion, an average of 13 weeks ]
    Assessing ApoB-containing lipoprotein fractional catabolic rate

  2. The role of this protein on glucose metabolism. [ Time Frame: through study completion, an average of 13 weeks ]
    Looking for glucose area under the curve following Oral Glucose Tolerance Test

  3. The role of ANPTL3 on fatty acids [ Time Frame: through study completion, an average of 13 weeks ]
    Looking for fatty acids area under the curve following Oral Fat Tolerance Test



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

      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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234724


Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: Marina Cuchel, MD, PhD University of Pennsylvania
  Study Documents (Full-Text)

Documents provided by University of Pennsylvania:
Informed Consent Form  [PDF] August 6, 2019

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04234724    
Other Study ID Numbers: 833684
R01HL148769 ( U.S. NIH Grant/Contract )
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Angiopoietin-like protein 3 deficiency
Lipid Metabolism