Completed

Investigation of Lipoprotein Metabolism Using Radiolabeled Apolipoproteins in Normal and Hyperlipoproteinemic Individuals

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Study Aim

This study aims to observe and understand lipoprotein metabolism in individuals with both normal and high lipoprotein levels, specifically focusing on dyslipidemia.

What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Lipid Metabolism, Inborn Errors+9

+ Metabolic Diseases

+ Metabolism, Inborn Errors

From 18 to 80 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Case-Only

Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.
Observational
Study Start: September 1976
See protocol details

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: September 1, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: September 3, 1976

Actual date on which the first participant was enrolled.

We propose to investigate human in vivo lipoprotein metabolism using radiolabeled apolipoproteins on plasma lipoproteins. Paired kinetic studies using dual-labeled iodinated lipoproteins and apolipoproteins are performed in healthy volunteer controls with normal lipids and subjects with dyslipidemia under controlled metabolic conditions. Studies are designed to formulate metabolic pathways in patients with undefined genetic disorders of lipid metabolism as well as in healthy volunteers to provide original insights into normal and pathologic metabolic pathways. All kinetic data is computer analyzed to provide quantitative data and facilitate direct comparison of multiple studies.

NCT00001154
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: September 1, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

759 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-only

These studies focus only on individuals who have a specific disease. Researchers examine patterns—often genetic or environmental—to uncover what might be linked to the condition.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Lipid Metabolism, Inborn ErrorsMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesGenetic Diseases, InbornLipid Metabolism DisordersHypercholesterolemiaHyperlipidemiasHypolipoproteinemiasDyslipidemiasHypoalphalipoproteinemias

Criteria

3 inclusion criteria required to participate
Euthyroid
Healthy normal volunteers - (18 years old or older) controls to investigate the formation of HDL for prebeta HDL
Subjects with new and undefined dyslipidemia-particularly familial disorders with extreme phenotypes
6 exclusion criteria prevent from participating
Allergic to iodine
Healthy control volunteers are initially screened for secondary causes of hyperlipidemia and are excluded if they have any clinically significant laboratory abnormality (i.e., liver disease, disease, kidney disease, endocrine disease,), chronic medical problems (i.e., hypertension, migraines, inflammatory bowel, hepatitis, HIV) or require any chronic medications (i.e., acne, asthma)
Pregnant women
The healthy control volunteers weight must fall within the current guidelines for ideal body weight
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institutes of Health Clinical Center

Bethesda, United StatesOpen National Institutes of Health Clinical Center in Google Maps
CompletedOne Study Center