NCT00108511

Brief Summary

The purpose of this study is to examine the role of glycosylphosphatidylinositol-specific phospholipase D (GPI-PLD) in triglyceride metabolism.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Oct 2004

Typical duration for phase_1

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

October 1, 2004

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 18, 2005

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 21, 2009

Status Verified

May 1, 2007

First QC Date

April 15, 2005

Last Update Submit

January 20, 2009

Conditions

Hypertriglyceridemia

Keywords

hypertriglyceridemialipoproteinstriglyceridesserum GPI-PLD (glycosylphosphatidylinositol-specific phospholipase D)

Interventions

GemfibrozilDRUG

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>18 and \<75
  • Fasting triglycerides \>150 mg/dl

You may not qualify if:

  • Fasting triglycerides \>600 mg/dl
  • LDL \>130 mg/dl
  • Concurrent lipid lowering therapy
  • Known hypersensitivity to gemfibrozil
  • Alcohol intake \>30 gm/day (2 drinks/day)
  • Fasting glucose \>125 mg/dl or known type 2 diabetes
  • AST or ALT \> 2.0 x upper limit of normal
  • Creatinine: men \>1.4 mg/dl, women \>1.3 mg/dl
  • Cancer treatment in the past 5 years (unless cured)
  • Infectious diseases including HIV or tuberculosis
  • Significant cardiac disease in the past 6 months (myocardial infarction, coronary artery bypass graph, angioplasty, class 3 or 4 congestive heart failure, left bundle branch block, third degree AV block)
  • Uncontrolled hypertension (systolic blood pressure \[SBP\] \>180 or diastolic blood pressure \[DBP\] \> 105 mm Hg)
  • Anemia (hematocrit \<40% men, \<35% women)
  • Any other significant systemic disease or medication that could interfere with tolerance of medication or outcome
  • Any indication that a participant will be unable to adhere to the protocol
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roudebush VA Medical Center

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Gemfibrozil

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Fibric AcidsIsobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsPentanoic AcidsValeratesPhenyl EthersEthersPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsFatty Acids, VolatileFatty AcidsLipids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
FED

Study Record Dates

First Submitted

April 15, 2005

First Posted

April 18, 2005

Study Start

October 1, 2004

Study Completion

September 1, 2007

Last Updated

January 21, 2009

Record last verified: 2007-05

Locations

US(1)