Evaluation of Lipoproteins

NCT00001168 | Completed

• 2 other identifiers: 79010079-H-0100
• Study Type: observational
• Target: 1,017
• Locations: 1 country
• Sites: 1

Brief Summary

Lipoproteins are particles that carry fats such as cholesterol and triglycerides through the blood stream. These particles are involved in causing blood vessel disease that can lead to conditions like hardening of the arteries (atherosclerosis) or heart attacks (myocardial infarctions). This study is designed to look closely at the factors affecting lipoproteins. Researchers plan to study patients and normal volunteers by measuring lipoprotein levels in the blood. Patients and volunteers will be placed on a balanced diet during the study. In addition, researchers plan to measure levels of various hormone and enzymes in the blood. Patients and volunteers participating in the study may be asked to undergo more specific tests in order to collect more information about lipoprotein metabolism. This study may not provide direct benefits to patients and volunteers participating in it. However, information gathered from this study may help researchers develop better skills and techniques to diagnose and treat patients with diseases of lipoprotein metabolism.

Conditions

Evaluation of Plasma Lipoproteins

Keywords

High Cholesterol; High HDL; Low HDL; LCAT Defiency; Natural History; Type III Hyperlipoproteinemia; Plasma Lipoproteins

Outcome Measures

Primary Outcomes (1)

• Screening and evaluation of individuals with potential disorders of lipid metabolism in order to provide training for professional Lipid Service staff in the evaluation and treatment of patients with genetic dyslipoproteinemias.

  Training for professional Lipid Service staff in the evaluation and treatment of patients with genetic dyslipoproteinemias

  Six years

Secondary Outcomes (1)

• Some of these patients may be candidates for enrollment in other Lipid Service research protocols.

  six years

Study Arms (1)

Dyslipidemia

Dyslipidemia

Behavioral: Balanced diet

Interventions

Balanced diet BEHAVIORAL

Dietary studies for the diagnosis of post-prandial hyperlipidemia will include a 3 week period while subjects are on a baseline, isoweight, 15% fat, 42% carbohydrate, normal polyunsaturated fat ratio (0.1-0.3) 250-300 mg cholesterol diet.

Dyslipidemia

Eligibility Criteria

• Age: 2 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

unlimited

You may qualify if:

• The following is a representative list of the types of patient presentations and potential diagnoses eligible for this protocol:
• Plasma cholesterol levels greater than 200 mg/dl or less than 120 mg/dl - includes patients with diagnoses such as familial hypercholesterolemia, familial combined hyperlipidemia, sitosterolemia, cholesteryl ester storage disease, Erdheim chester disease, lipoprotein lipase, hepatic lipase or apo-CII deficiency, and dysbetalipoproteinemia.
• Plasma LDL-C levels greater than 130 mg/dl or less than 70 mg/dl - includes patients with diagnoses such as familial hypercholesterolemia, familial combined hyperlipidemia, lipoprotein lipase, hepatic lipase, or apo-CII deficiency, sitosterolemia, dysbetalipoproteinemia, abetalipoproteinemia and hypobetalipoproteinemia.
• Plasma HDL-C levels greater than 70 mg/dl or less than 25 mg/dl - includes patients with deficiency of cholesteryl ester transfer protein, lecithin cholesterol acyltransferase, phospholipid transfer protein, lipoprotein lipase, hepatic lipase, or apo-CII, and Tangier disease.
• Plasma triglyceride levels greater than 150 mg/dl - includes patients with deficiency of lipoprotein lipase, hepatic lipase or apoC-II, dysbetalipoproteinemia, Type IV and Type V hyperlipidemia.

You may not qualify if:

• Inability to provide informed consent.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hypercholesterolemia; Hyperlipoproteinemia Type III

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Lipid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperlipoproteinemias

Study Officials

• Robert D Shamburek, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: January 1, 1979
• Last Updated: May 22, 2026

Record last verified: 2025-08-19

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)