Status:
COMPLETED
Effect of Gemfibrozil on Serum Glycosylphosphatidylinositol (GPI) Phospholipase D and Triglycerides
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
19-74 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to examine the role of glycosylphosphatidylinositol-specific phospholipase D (GPI-PLD) in triglyceride metabolism.
Detailed Description
Increased fasting serum triglyceride levels are associated with an increased risk of coronary artery disease. However, triglyceride levels in the postprandial state are a more sensitive marker of coro...
Eligibility Criteria
Inclusion
- Age \>18 and \<75
- Fasting triglycerides \>150 mg/dl
Exclusion
- 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
- Unable to give informed consent
- Pregnant or breastfeeding females or a female who plans to become pregnant while participating in the study
Key Trial Info
Start Date :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00108511
Start Date
October 1 2004
End Date
September 1 2007
Last Update
January 21 2009
Active Locations (1)
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1
Roudebush VA Medical Center
Indianapolis, Indiana, United States, 46202