Mendelian Reverse Cholesterol Transport Study (NCT01782027) | Clinical Trial Compass
TerminatedNot Applicable
Mendelian Reverse Cholesterol Transport Study
Stopped: Lack of funding
United States17 participantsStarted 2012-10
Plain-language summary
The purpose of this study is to investigate the use of radiolabeled particulate cholesterol administered intravenously in association with albumin, as a method to study reverse cholesterol transport (RCT) in people carrying mutations in genes known to affect high density lipoprotein (HDL) metabolism by analyzing changes in the tracer activity in total plasma, lipoproteins fractions and feces.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Men and women between the ages of 18 and 75
✓. Subjects must be:
✓. Carriers of functional mutations of genes encoding proteins affecting HDL metabolism;
✓. Healthy control subjects with HDL cholesterol levels within the normal range of the lab where screening tests are run, or at the discretion of the investigator, and matched for gender, race, age (± 5 years) to the patients.
✓. Negative screening pregnancy test if female of child bearing potential (females of child-bearing potential must be following a medically accepted form of contraception)
✓. Subjects must be able to comprehend and willing to provide a signed IRB approved Informed Consent Form.
✓. Subjects must be willing and able to comply with all study-related procedures.
Exclusion criteria
✕. Known cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease (control subjects only)
What they're measuring
1
determination of 3H cholesterol in plasma and lipoproteins
. History of diabetes mellitus or fasting glucose \> 126 mg/dL at the screening visit (control subjects only).
✕. Any current, unstable endocrine disease as assessed by collection of medical history during screening. Subjects with rare Mendelian disorders with thyroid disease that is well controlled by stable treatment may be considered for enrollment at the discretion of the principal investigator
✕. History of previous malignancy, other than basal cell or squamous cell carcinoma of the skin, from which the patient has been disease free for less than 5 years as assessed by collection of medical history during screening
✕. Current diagnosis of anemia as assessed by collection of medical history during screening or hemoglobin less than 10 g/dL as evaluated during safety lab at screening
✕. History of kidney disease or chronic renal insufficiency, as defined as estimated glomerular filtration rate (eGFR) \< 60 ml/min/1.73m2 in control subjects and patients with other disorders of HDL metabolism and eGFR \< 30 ml/min/1.73m2 in subjects with Lecithin-Cholesterol Acyltransferase (LCAT) deficiency.
✕. Any active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition as assessed by collection of medical history during screening, and judged by the investigator to be a major condition.
✕. Sustained uncontrolled hypertension (Systolic \>160 mm Hg and/or Diastolic BP \>100 mmHg) at screening. Blood pressure may be re-tested twice after initial assessment in the supine position at five minute intervals (for a total of 3 blood pressure assessments). The pressure elevation is considered sustained if either the systolic or the diastolic pressure values are outside the stated limits for all three assessments