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Look AHEAD: Action for Health in Diabetes Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Look AHEAD: Action for Health in Diabetes conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Look AHEAD: Action for Health in Diabetes Clinical research trials and Look AHEAD: Action for Health in Diabetes healthcare trials happen in a lot of of localities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Look AHEAD: Action for Health in Diabetes. Look AHEAD: Action for Health in Diabetes Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Look AHEAD: Action for Health in Diabetes clinical trial. Human subjects often receive the most effective healthcare possible for their Look AHEAD: Action for Health in Diabetes condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Look AHEAD: Action for Health in Diabetes  Look AHEAD: Action for Health in Diabetes
Look AHEAD: Action for Health in Diabetes
For Condition: Diabetes,Bone Diseases,Dyslipidemia,Myocardial Infarction,Stroke,Kidney Diseases
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) , National Heart, Lung, and Blood Institute (NHLBI),National Institute of Nursing Research (NINR),National Center on Minority Health and Health Disparities (NCMHD),Office of Research on Women's Health (ORWH)
Synopsis: The Look AHEAD study is a multicenter, randomized clinical trial to examine the long-term effects of a lifestyle intervention designed to achieve and maintain weight loss. The study will investigate the effects of the intervention on heart attacks, stroke and cardiovascular-related death in individuals with type 2 diabetes who are also overweight or obese.
Details: Research has shown that weight loss has many short-term benefits, such as improvements in blood pressure, but we do not know if attempts to lose weight over the long term are beneficial. Some studies even suggest that losing weight may lead to health problems such as gall bladder disease and bone loss. Look AHEAD will help us understand the long-term effects of weight loss on health, and see if it helps reduce heart attacks and strokes. We hope to learn the long-term benefits and risks of a program designed to achieve and maintain weight loss. The study will consist of two groups of volunteers. One group will be asked to eat fewer calories and increase their physical activity. This group will be compared to a second group who will receive diabetes support and education. Both groups will receive medical monitoring. In addition to heart attacks and stroke, Look AHEAD will study the effects of the interventions on other factors relating to heart disease, on diabetes control and complications, and on relative costs and quality of life associated with the interventions. Overall, this study will help doctors in the future in advising their patients who have diabetes about losing weight. About 5,000 men and women in 19 cities around the country will take part in the study. The study will last 9 to 11.5 years: the length of time will depend on when the individual starts the study.
Eligibility:
Study Type: Interventional, Treatment, Open Label
Minimum Age/Maximum Age: 55 Years/75 Years
Genders: Both
Protocol Entry 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.
Total Enrollment: 5000
Location and Contact Information:
University of Minnesota
Minneapolis, Minnesota, 55415-1226
United States
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
United States
UCLA Diabetes Center
Alhambra, California, 91801
United States
Northern Navajo Medical Center
Shiprock, New Mexico, 87420
United States
Southwestern American Indian Center
Phoenix, Arizona, 85014
United States
Johns Hopkins Pro-Health
Baltimore, Maryland, 21207
United States
University of Washington
Seattle, Washington, 98108
United States
University of Texas Health Sciences Center
San Antonio, Texas, 78229
United States
Baylor College of Medicine
Houston, Texas, 77030
United States
Diabetes Center
Boston, Massachusetts, 02114
United States
Roosevelt Hospital
New York City, New York, 10019
United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
United States
University of Colorado Health Sciences Center
Aurora, Colorado, 80045-0808
United States
The University of Alabama at Birmingham
Birmingham, Alabama, 35205
United States
The Miriam Hospital
Providence, Rhode Island, 02906
United States
Joslin Diabetes Center
Boston, Massachusetts, 02114
United States
The University of Tennessee, Memphis
Memphis, Tennessee, 38105
United States
Louisiana State University
Baton Rouge, Louisiana, 70808
United States
Additional Information:
Study ID Numbers: SHOW; U01DK57136,U01DK57178,U01DK57171,U01DK57135,U01DK57008,U01DK57002,U01DK57151,U01DK57078,U01DK57131,U01DK219,U01DK57154,U01DK56990,U01DK57149,U01DK57177,U01DK56992,U01DK57182
Study Start Date: June 2001
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017953
Other Bone Diseases Studies:
1. Evaluation of the Safety & Efficacy of a Combination of Niacin ER & Simvastatin in Patients with Dyslipidemia (OCEANS)
2. A Study of Physical and Metabolic Abnormalities in HIV Infected and Uninfected Children and Youth
3. Look AHEAD: Action for Health in Diabetes
4. Safety & Efficacy of a Combination Niacin ER/Simvastatin in Patients with Dyslipidemia: A Dose-Ranging Study - SEACOAST
5. Obese Patients with Untreated Dyslipidemias
Related Studies:
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Look AHEAD: Action for Health in Diabetes
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