NCT00953667

Brief Summary

The purpose of this study is to determine genetic factors that affect responses to niacin therapy and endotoxemia in healthy volunteers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable healthy-volunteers

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

March 24, 2016

Completed
Last Updated

March 24, 2016

Status Verified

January 1, 2016

Enrollment Period

3.7 years

First QC Date

August 4, 2009

Results QC Date

July 29, 2015

Last Update Submit

February 23, 2016

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Baseline and Peak TNF-alpha Values as Categorized by Race and Gender

    Baseline (-15 min, -5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS

Secondary Outcomes (1)

  • Baseline and Peak C-Reactive Protein (CRP) Values as Categorized by Race and Gender

    Baseline ( -15 min, -5 min), and 1, 2, 4, 6, 12, 18, and 24 hours post LPS

Study Arms (1)

Niacin and Endotoxin

EXPERIMENTAL

All subjects are expected to have the same interventions- Niacin and Endotoxin.

Drug: Immediate Release Niacin, Extended Release Niacin, Endotoxin

Interventions

Immediate Release Niacin, Extended Release Niacin, EndotoxinDRUG

Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).

Also known as: Niacor, Niaspan
Niacin and Endotoxin

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

  • Ferguson JF, Xue C, Gao Y, Tian T, Shi J, Zhang X, Wang Y, Li YD, Wei Z, Li M, Zhang H, Reilly MP. Tissue-Specific Differential Expression of Novel Genes and Long Intergenic Noncoding RNAs in Humans With Extreme Response to Evoked Endotoxemia. Circ Genom Precis Med. 2018 Nov;11(11):e001907. doi: 10.1161/CIRCGEN.117.001907.

    PMID: 30571184DERIVED

  • Ferguson JF, Shah RY, Shah R, Mehta NN, Rickels MR, Reilly MP. Activation of innate immunity modulates insulin sensitivity, glucose effectiveness and pancreatic beta-cell function in both African ancestry and European ancestry healthy humans. Metabolism. 2015 Apr;64(4):513-520. doi: 10.1016/j.metabol.2014.12.007. Epub 2014 Dec 26.

    PMID: 25579865DERIVED

  • Ferguson JF, Ryan MF, Gibney ER, Brennan L, Roche HM, Reilly MP. Dietary isoflavone intake is associated with evoked responses to inflammatory cardiometabolic stimuli and improved glucose homeostasis in healthy volunteers. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):996-1003. doi: 10.1016/j.numecd.2014.03.010. Epub 2014 Apr 18.

    PMID: 24875672DERIVED

  • Liu Y, Ferguson JF, Xue C, Ballantyne RL, Silverman IM, Gosai SJ, Serfecz J, Morley MP, Gregory BD, Li M, Reilly MP. Tissue-specific RNA-Seq in human evoked inflammation identifies blood and adipose LincRNA signatures of cardiometabolic diseases. Arterioscler Thromb Vasc Biol. 2014 Apr;34(4):902-12. doi: 10.1161/ATVBAHA.113.303123. Epub 2014 Feb 6.

    PMID: 24504737DERIVED

  • Ferguson JF, Patel PN, Shah RY, Mulvey CK, Gadi R, Nijjar PS, Usman HM, Mehta NN, Shah R, Master SR, Propert KJ, Reilly MP. Race and gender variation in response to evoked inflammation. J Transl Med. 2013 Mar 12;11:63. doi: 10.1186/1479-5876-11-63.

    PMID: 23497455DERIVED

MeSH Terms

Interventions

EndotoxinsNiacin

Intervention Hierarchy (Ancestors)

Bacterial ToxinsToxins, BiologicalBiological FactorsNicotinic AcidsAcids, HeterocyclicHeterocyclic CompoundsPyridinesHeterocyclic Compounds, 1-Ring

Results Point of Contact

Title
Muredach Reilly
Organization
UPenn
muredach@mail.med.upenn.edu
215-573-1214

Study Officials

  • Muredach P Reilly, M.B., MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

June 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

March 24, 2016

Results First Posted

March 24, 2016

Record last verified: 2016-01

Locations

US(1)