Look AHEAD: Action for Health in Diabetes "Look AHEAD"

Active, not recruiting

Phase N/A Results N/A

Eligibility Criteria

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).
- 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.
- 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.