N/A
N=400
The Genetics of Evoked Responses to Niacin and Endotoxemia: The GENE Study
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT00953667 ↗Enrolled (actual)
400
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Baseline and Peak TNF-alpha Values as Categorized by Race and Gender — 1.08; 43.48; 1.03; 37.28 pg/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immediate Release Niacin, Extended Release Niacin, Endotoxin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline and Peak TNF-alpha Values as Categorized by Race and Gender |
1.08; 43.48; 1.03; 37.28; 1.06; 43.23 | — |
| SECONDARY Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender |
0.34; 17.8; 0.54; 14.25; 0.62; 15.9 | — |
Summary
The purpose of this study is to determine genetic factors that affect responses to niacin therapy and endotoxemia in healthy volunteers.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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.
Data sourced from ClinicalTrials.gov (NCT00953667). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.