Cardiovascular Diseases, Heart Diseases
Conditions
Keywords
Heart diseases, Cardiovascular diseases, Lifestyle modification, Diet, Exercise
Brief summary
The purpose of this study is to characterize changes in gene and protein expression in peripheral blood in patients with, or at risk for, heart disease during an intensive lifestyle modification program.
Detailed description
This project will use an integrated approach that examines DNA variation and the functional products of genes at both the messenger RNA (mRNA) and protein levels to provide a global view of molecular changes associated with drastic lifestyle modifications designed to reverse coronary heart disease (CHD). DNA variants and/or changes in gene and protein expression associated with CHD reversal may provide important clues to understanding molecular mechanisms of subclinical CHD development and progression.
Interventions
Prospective, nonrandomized clinical intervention to stabilize or reverse progression of heart disease through changes in lifestyle. Lifestyle intervention consisted of four components: 1) a very low fat vegetarian diet (\<10% of calories from fat); 2) 180 minutes/week of moderate aerobic exercise; 3) one hour of stress management each day; and 4) weekly group support sessions.
Sponsors
Windber Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of coronary artery disease (CAD) * stable angina * angioplasty * evidence of \>50% luminal narrowing on coronary angiogram * acute myocardial infarction * bypass surgery * stent placement OR * two or more CAD risk factors * systolic pressure \>140 mm Hg or diastolic pressure \>90 mm Hg) * high total cholesterol (\>200 mg/dL) * physician diagnosed diabetes * body mass index (BMI) \>30 * family history of heart disease in parents or siblings * 21 years of age or older * mentally competent to provide informed consent
Exclusion criteria
* known history of autoimmune disease * systemic/chronic disease requiring chemotherapy or long term treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index | Baseline, 12 weeks, 52 weeks | Change in BMI from baseline to 12 weeks and from baseline to 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in blood pressure | Baseline, 12 weeks, 52 weeks | Change in BP from baseline to 12 weeks and from baseline to 52 weeks |
| Change in lipids | Baseline, 12 weeks, 52 weeks | Change in HDL-, LDL-, total cholesterol, and triglycerides from baseline to 12 weeks and from baseline to 52 weeks |
| Change in exercise capacity | Baseline, 12 weeks, 52 weeks | Change in exercise capacity from baseline to 12 weeks and from baseline to 52 weeks |
Countries
United States
Outcome results
None listed