Recruiting NCT04234724
Physiological Effects of ANGPTL3 Variants in Humans
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Kinetics test, oral fat tolerance test, and an oral glucose tolerance test..
- Who it may be relevant to
- Registry conditions: Hypocholesterolemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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
- The role of ANGPTL3 on lipid metabolism. [Time frame: through study completion, an average of 13 weeks]
- The role of this protein on glucose metabolism. [Time frame: through study completion, an average of 13 weeks]
- The role of ANPTL3 on fatty acids [Time frame: through study completion, an average of 13 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT04234724 · 833684 · R01HL148769