Effects of ANGPTL3 Variants on Lipid and Glucose Metabolism
Physiological Effects of ANGPTL3 Variants in Humans
NA · University of Pennsylvania · NCT04234724
This study is testing how certain genetic changes in the ANGPTL3 protein affect fat and sugar processing in people with these changes compared to those without them.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania (other) |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04234724 on ClinicalTrials.gov |
What this trial studies
This study evaluates the role of ANGPTL3, a protein involved in lipid metabolism, by conducting oral fat tolerance tests and glucose tolerance tests. Participants will include individuals with genetic variants in the ANGPTL3 gene and matched unaffected controls. The study aims to understand how these variants affect lipid and glucose metabolism, which could have implications for managing conditions like hypocholesterolemia.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 or older with genetic variants in the ANGPTL3 gene or matched unaffected controls.
Not a fit: Patients with significant medical or psychological conditions, or those on medications that could interfere with the study, may not benefit from participation.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of lipid metabolism disorders, potentially benefiting patients with hypocholesterolemia.
How similar studies have performed: Other studies have explored the role of ANGPTL3 in lipid metabolism, suggesting potential for success in this area.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (RECRUITING)
Study contacts
- Principal investigator: Marina Cuchel, MD, PhD — University of Pennsylvania
- Study coordinator: Marina Cuchel, MD, PhD
- Email: mcuchel@pennmedicine.upenn.edu
- Phone: 215-662-7188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hypocholesterolemia, Angiopoietin-like protein 3 deficiency, Lipid Metabolism