Metabolic Syndrome Clinical Trial
Official title:
Slowing HEART diSease With Lifestyle and Omega-3 Fatty Acids (HEARTS)
The purpose of the study is to target inflammation to reduce progression of noncalcified plaque in the coronary arteries using omega-3 fatty acid supplementation compared to standard of care.
Study Design: This is a randomized, parallel study design with a usual care control group.
278 subjects with coronary heart disease (CHD) are being randomized to omega-3
supplementation or standard of care (139 in each arm).
Multidetector computed tomographic angiography (MDCTA) is performed at baseline to quantitate
the amount of noncalcified and calcified coronary plaque and again at 30 month follow-up to
determine if there has been a change in the volume of noncalcified or total plaque. The
primary endpoint is change in coronary noncalcified plaque volume during the 30 months of
intervention between active and standard of care.
Hypothesis: Percent change in progression of coronary plaque volume will be less for the
omega-3 fatty acid intervention compared to standard of care.
Secondary endpoints include plasma levels of inflammatory markers, lipids and measures of
insulin sensitivity.
Secondary outcomes include testing the hypothesis that targeting inflammation with omega-3
fatty acids will be associated with:
1. Change in total plaque volume per patient.
2. improvement in physical function and exercise and reduction in pain and stiffness as
measured by the WOMAC questionnaire
3. Reduction of mediators of inflammation in the circulation including CRP, PAI-1, serum
amyloid A, MMP-9 and fibrinogen, pro-inflammatory cytokines including IL-6, TNF-a and
IL-1b, the adhesion molecules VCAM-1 and ICAM-1, increase in adiponectin and reduction
in serum nitrotyrosine as a marker of oxidative stress.
4. Reduction of insulin resistance assessed by fasting insulin and homeostasis model
assessment of insulin resistance (HOMA-IR).
5. Reduction of inflammation in the liver associated with nonalcoholic steatohepatitis
(NASH), a newly recognized component of the metabolic syndrome, and reduction of fatty
liver quantitated by computerized tomography and levels of AST and ALT as markers of
liver inflammation related to NASH.
6. Investigation of the relationship between vitamin D status and coronary plaque
progression as well as with insulin resistance (HOMA-IR), beta-cell function
(HOMA-%beta) and inflammatory cytokines.
7. Determination of whether baseline vitamin D levels predict clinical response to the
omega-3 fatty acid intervention, and whether hypovitaminosis D is associated with plaque
progression.
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