CClinicalTrials.gg
CompletedNCT00001154Updated Sep 8, 2026

Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins

An observational study in Hypolipoproteinemia, Hypercholesterolemia and Dyslipidemia, sponsored by National Heart, Lung, and Blood Institute (NHLBI). Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by National Heart, Lung, and Blood Institute (NHLBI) · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
759
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Researchers plan to study the fat-rich particles, called lipoproteins, which circulate in the blood. This study is designed to improve understanding of normal, as well as abnormal, lipoprotein metabolism and the role it plays in the development of hardening of the arteries (atherosclerosis).

Patients participating in this study will receive injections of lipoproteins or apolipoproteins (the protein component of lipoproteins) that have been isolated and purified. These lipoproteins will be labeled with small amounts of radioactive material and sterilized before they are injected into the patient.

Patients participating in the study will be required to have blood samples taken, and provide urine samples throughout the course of the study. In addition, patient will be required to follow a specially formulated diet. Patients will be weighed throughout the course of the study.

Read the detailed description

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.

02

Conditions studied

  • Hypolipoproteinemia
  • Hypercholesterolemia
  • Dyslipidemia
  • Hyperlipidemia

Keywords

  • Metabolism
  • HDL
  • Cholesterol
  • LDL
  • Hypoalphalipoproteinemia
  • Natural History
03

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's enrollment of 759 is close to the median of 800 across 185 observational studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI) is the lead sponsor of 1,117 studies on the registry; 71 are open to participants now.

Of its 57 completed or terminated interventional studies of FDA-regulated products, 49 (86%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Dsylipidemia

Inclusion criteria

Subjects with new and undefined dyslipidemia-particularly familial disorders with extreme phenotypes.

Healthy normal volunteers - (18 years old or older) controls to investigate the formation of HDL for prebeta HDL.

Euthyroid.

Exclusion criteria

EXCLUSION CRITERIA:

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).

The healthy control volunteers weight must fall within the current guidelines for ideal body weight.

Pregnant women.

Unwilling to follow metabolic diet.

Allergic to iodine.

Unable to sign consent form.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
759 participants (actual)

Groups and cohorts

  • Patients

    Subjects with new and undefined dyslipidemia

06

What researchers measure

Primary outcomes

  1. No outcome. This is a disease discover protocol.

    Dyslipidemia

    Time frame: 5 years

07

Study locations

1 site
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00001154
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Nov 4, 1999
Start date
Sep 3, 1976
Last update
Sep 8, 2026

Study contacts

Robert D Shamburek, M.D.
principal investigator · National Heart, Lung, and Blood Institute (NHLBI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion