Status:
COMPLETED
The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study
Lead Sponsor:
University of Pennsylvania
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-45 years
Phase:
NA
Brief Summary
The purpose of this study is to determine genetic factors that affect responses to niacin therapy and endotoxemia in healthy volunteers.
Detailed Description
Niacin is a vitamin that has beneficial effects on cholesterol (a type of fat in the blood) when used in high doses. Different people respond differently to cholesterol lowering doses of niacin, some ...
Eligibility Criteria
Inclusion
- Men and non-pregnant/lactating women between the ages of 18 and 45.
- Self reported African American or Caucasian racial-ethnic background.
- Body Mass Index (BMI) of ≥ 18 and ≤ 30.
- Participants who are able to give written informed consent and willing to comply with all study-related procedures.
Exclusion
- Known clinically manifest atherosclerotic cardiovascular disease, including coronary disease, cerebrovascular disease, or peripheral vascular disease.
- History of diabetes mellitus.
- Fasting glucose \> 126 mg/dL.
- History of a non-skin malignancy within the previous 5 years.
- Renal insufficiency as defined by creatinine \> 1.5 mg/dl at Screening Visit.
- History of liver disease or abnormal liver function tests (LFTs) (AST, ALT, Alk. Phos., GGT \> 1.5x upper limit of normal (ULN); bilirubin \> 2x ULN) at Screening Visit.
- Men who are unwilling to limit alcohol consumption to \<14 alcoholic drinks per week or \< 4 alcoholic drinks per occasion (AMA / NIAAA criteria for "at risk" usage levels) while participating in the study.
- Women who are unwilling to limit alcohol consumption to \< 7 alcoholic drinks per week or \< 3 alcoholic drinks per occasion (AMA / NIAAA criteria for "at risk" usage levels) while participating in the study.
- Total white blood cell count less than or equal to 3.0 THO/uL.
- Hemoglobin below 11.0 g/dL.
- Any major active rheumatologic, pulmonary, or dermatologic disease or inflammatory condition or minor active infection.
- History of HIV positive.
- First degree family history of premature cardiovascular disease event (father or brother if diagnosed at before 55 years of age; mother or sister if diagnosed before 65 years of age).
- Patients who have undergone any organ transplant.
- Individuals who currently use tobacco products or have done so in the previous 30 days.
- Treatment with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), COX-2 inhibitors, steroids or any immunomodulatory therapy 2 weeks prior to the Screening Visit.
- Treatment with statins, fibrates or niacin 4 weeks prior to the Screening Visit.
- Current daily use of Vitamin C \> 1000 mg, Beta carotene \> 1000 IU, vitamin A \> 5000 IU, vitamin E \> 400 IU, and selenium \> 200 mcg.
- Positive urine pregnancy at the Screening Visit.
- Participation in another clinical trial within the previous 6 weeks prior to the Screening Visit.
- Poorly controlled blood pressure (BP \> 160/110) or on any anti-hypertensive medications.
- A diagnosis of metabolic syndrome using updated 2004 NCEP ATPIII criteria.
- A history of severe lactose intolerance (e.g., intolerance of any milk intake).
- Any medical condition or abnormal laboratory value that is judged clinically significant by an investigator.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT00953667
Start Date
June 1 2007
End Date
February 1 2011
Last Update
March 24 2016
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104