Effect of Gemfibrozil on Serum Glycosylphosphatidylinositol (GPI) Phospholipase D and Triglycerides

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: US Department of Veterans Affairs; VA Office of Research and Development
• Treatments: Gemfibrozil

Criteria

Inclusion Criteria:

• Age >18 and <75

• Fasting triglycerides >150 mg/dl

Exclusion Criteria:

• 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