Look AHEAD: Action for Health in Diabetes

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.