Please select the eligibility criteria that correspond to the clinical trial below.
Title: The Effect of an Enhanced Dietary Portfolio Plus Exercise on Cardiovascular Risk in High Risk Individuals.
Brief Summary: "Is it possible to recruit and retain up to 200 participants in a Randomize Control Trial (RCT) of high impact lifestyle approach of diet and exercise designed to significantly reduce cardiovascular events in middle-aged and older men and women at high risk of such events?" To address this question, we propose a pilot study of 3 years in duration: 1 year recruitment and randomization, a full year of intervention for all recruited participants, and the last 6 months to assess the one year data and prepare and submit the full trial application, informed by the pilot study outcomes in terms of retention rate. The pilot will then continue on for the full 9 years of intervention and be rolled into the main study involving additional Canadian centers and collaborating international centers in the US, Britain, Europe, Australia, New Zealand, India, and South Africa.


Options:
A: Inclusion Criteria:

* Type 2 diabetes
* Overweight
* BMI of 25 kg/m2 or greater
* If on insulin, BMI of 27 kg/m2 or greater
* Blood pressure less than 160/100 mmHg
* HbA1c less or equal to 11%
* Triglycerides less than 600 mg/dl
* Willingness to participate

Exclusion Criteria:

* Unable or unwilling to give informed consent or communicate with local study staff.
* Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder.
* Hospitalization for depression in past six months.
* Self-report of alcohol or substance abuse within the past twelve months.
* Current consumption of more than 14 alcoholic drinks per week.
* Current acute treatment or rehabilitation program for these problems.
* Plans to relocate to an area not served by Look AHEAD or travel plans that do not permit full participation in the study.
* Lack of support from primary care health provider or family members.
* Failure to complete the two-week run-in for dietary intake and exercise.
* Weight loss exceeding 10 lbs. in past three months.
* Current use of medications for weight loss.
* Self reported inability to walk two blocks.
* History of bariatric surgery, small bowel resection, or extensive bowel resection.
* Chronic treatment with systemic corticosteroids.
* Another member of the household is a participant or staff member in Look AHEAD.
* Currently pregnant or nursing.
* Cancer requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured.
* HIV positive (self-report), due to effects on weight and body composition of HIV and medications used to treat HIV.
* Active tuberculosis (self-report).
* Cardiovascular disease (heart attack or procedure within the past three months).
* Participation in a cardiac rehabilitation program within last three months.
* Stroke or history/treatment for transient ischemic attacks in the past three months.
* Pulmonary embolus in past six months.
* Unstable angina pectoris or angina pectoris at rest.
* A history of cardiac arrest.
* Complex ventricular arrhythmia at rest or with exercise (e.g., ventricular tachycardia).
* Uncontrolled atrial fibrillation (heart rate of 100 beats per minute or more).
* New York Heart Association (NYHA) Class III or IV congestive heart failure.
* Acute myocarditis, pericarditis or hypertrophic myocardiopathy.
* Clinically significant aortic stenosis.
* Left bundle branch block or cardiac pacemaker unless evaluated and cleared for participation by a cardiologist.
* Cardiac defibrillator.
* Heart transplant.
* History of aortic aneurysm of at least 7 cm in diameter or aortic aneurysm repair.
* Resting heart rate less than 45 beats per minute or greater than 100 beats per minute.
* Any abnormality during the maximum exercise stress test that indicates that it would be unsafe to participate in the Lifestyle Intervention.
* Angina pectoris.
* Significant ST segment depression at low levels of exercise. (ST segment is the flat, isoelectric section of the ECG between the end of the S wave (the J point) and the beginning of the T wave)
* Exercise induced ventricular arrhythmias.
* Abnormal hemodynamics, such as flat or decreasing systolic blood pressure with increasing workload.
* Those at moderate to high risk for cardiac complications during exercise.
* Those who are unable to self-regulate activity or understand the recommended activity level.
* Renal disease or dialysis.
* Chronic obstructive pulmonary disease that would limit ability to follow the protocol.
* Self-reported chronic hepatitis B or C or cirrhosis.
* Inflammatory bowel disease requiring treatment in past year.
* Cushing's syndrome.
* Acromegaly.
* Amputation of lower limbs as result of non-traumatic causes.
* Any major organ transplant.
B: A) Inclusion Criteria:

Eligible participants will be:

1. men, over 50
2. postmenopausal women, over 60 or
3. postmenopausal women under 60 with a family history of hypercholesterolemia and 1 CVD risk factor.

Participants will have the following characteristics:

* BMI 25-40 kg/m2 with body weight that has remained constant (within ±3%) over the last 3 months preceding the onset of the study
* Plus at least 1 of the following 3 criteria:

  1. have type 2 diabetes with one of the following:

     * raised LDL-C(in accordance with the 2012 Canadian Cardiovascular Society Guidelines)
     * raised BP (\> 130/80mmHg), or
     * active smoking;
  2. be non-diabetic subjects post MI or post percutaneous coronary intervention (angioplasty) on statin therapy; and
  3. have a modified Framingham risk score \>20% (CCS 2012) and are unable (intolerant) or unwilling to take statin drugs.

B) Exclusion Criteria:

Individuals with the following conditions will be excluded:

* cardiovascular disease that precludes exercise e.g.

  * recent stroke or
  * myocardial infarction, or
* cardiac condition that compromises normal function

  * mitral valve disease,
  * heart failure--grades 2-4 (New York Heart Association classification),
  * severe angina or
  * other conditions preventing exercise,
* secondary causes of hypercholesterolemia

  * hypothyroidism, (unless treated and on a stable dose of L-thyroxine)
  * renal or liver disease
* uncontrolled blood pressure
* major disability
* disorder requiring continuous medical attention and treatment:

  * chronic heart failure,
  * liver disease,
  * renal failure or
  * cancer (except non-melanoma skin cancer--basal cell, squamous cell),
* chronic infections (bacterial or viral)
* chronic inflammatory diseases (e.g. lupus, ulcerative colitis)
* other autoimmune diseases
* major surgery \<6 months prior to randomization
* alcohol consumption \>2 drinks/d.
C: Inclusion Criteria:

* BMI of 27-40 kg/m2
* 30-75 years of age
* Stable body weight for the preceding 6 months
* Diagnosis of type 2 diabetes for at least 6 months prior to enrollment
* HbA1c of 6.5 to 9.0
* Treatment by diet or oral agents only

Exclusion Criteria:

* Pregnancy or lactation
* Active cardiac, pulmonary, renal, liver, or gastrointestinal disease
* Untreated thyroid disease or hypertension
* Hypertriglyceridemia with levels of TG \> 500 mg/dl
* Use of insulin
* Use of specific medications that may alter lipid or glucose metabolism (other than the statins)
* Use of medications that commonly cause significant alterations in body weight (e.g., corticosteroids).
D: Inclusion Criteria:

* Men or women age 30-65,
* BMI in the range 28-35 kg/m2 for women and 28-40kg/m2 for men.
* At least one of the following components of the metabolic syndrome; fasting triglycerides \> 1,7, fasting glucose 6,0-6,9, HDL-cholesterol \<1,03 (males) or \<1,29 (females), Blood pressure \>130/85 (with or without treatment), diet-treated diabetes mellitus or drug treated hypertension.
* Stable weight range of 4 kg or less the last 12 weeks,
* No major change in physical activity the last 12 weeks

Exclusion Criteria:

* Any symptomatic cardiovascular disease
* Diabetes requiring drug treatment
* Currently on special diet
* Hepatic/renal dysfunction
* Hypothyroidism (unstable)
* GI disorder impairing compliance with diet recommendation,
* History of unstable psychiatric or medical disorder,
* Need of lipid lowering drug,
* Alcohol or drug abuse,
* Participation in drug trial the last 30 days,
* Use of drugs for weight reduction last 12 weeks, pregnancy or planned pregnancy,
* Obesity of known endocrine origin, history of obesity surgery,
* Uncontrolled hypertension (\>160/100),
* Previous participation in \>3 weight reduction programs, or within last 12 months,
* Not willing to be randomized,
* Individual judged to be unable to follow instructions and procedures of the study

Answer: B