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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL148769 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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To evaluate the role of ANGPTL3, on lipid metabolism. To explore the role of this protein on glucose metabolism.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Variant | Experimental | Volunteers with known ANGPTL3 variants |
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| Non-variant | Other | Healthy volunteers with no ANGPTL3 variants |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kinetics test, oral fat tolerance test, and an oral glucose tolerance test. | Other | Subjects will participate in a kinetics test, oral fat tolerance test, and an oral glucose tolerance test. |
| Measure | Description | Time Frame |
|---|---|---|
| The role of ANGPTL3 on lipid metabolism. | Assessing ApoB-containing lipoprotein fractional catabolic rate | through study completion, an average of 13 weeks |
| The role of this protein on glucose metabolism. | Looking for glucose area under the curve following Oral Glucose Tolerance Test | through study completion, an average of 13 weeks |
| The role of ANPTL3 on fatty acids | Looking for fatty acids area under the curve following Oral Fat Tolerance Test | through study completion, an average of 13 weeks |
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Inclusion Criteria:
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
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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marina Cuchel, MD, PhD | Contact | 215-662-7188 | mcuchel@pennmedicine.upenn.edu |
| Name | Affiliation | Role |
|---|---|---|
| Marina Cuchel, MD, PhD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 6, 2019 | Jan 13, 2020 | ICF_000.pdf |
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