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About Us
LABS Factsheet
Bariatric surgical procedures, which restrict stomach size and/or lead to decreased absorption of nutrients, are being increasingly performed to treat extreme obesity. These procedures can have dramatic benefits, such as improved control of blood sugar or even reversal of type 2 diabetes, but also carry substantial risks, including death. Although an increasing number of persons with extreme obesity are undergoing bariatric surgical procedures, there has been little systematic research to help determine the risks and benefits of bariatric surgery, or to provide guidance on appropriate patient selection. To facilitate and accelerate research in this area, the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established a bariatric surgery clinical research consortium, now known as the Longitudinal Assessment of Bariatric Surgery, or LABS.
The NIH has brought together the Longitudinal Assessment of Bariatric Surgery researchers with expertise in bariatric surgery, obesity research, internal medicine, endocrinology, behavioral science, outcomes research, epidemiology, and other relevant fields to collaboratively plan and conduct studies that will ultimately lead to better understanding of bariatric surgery and its impact on the health and well-being of patients with extreme obesity.
The consortium will develop a database for collecting standardized information on patients undergoing bariatric surgery at the participating clinical centers. This database will greatly assist in developing evidence-based information regarding the risks and benefits of bariatric surgery. Rigorously collected information on patient characteristics, surgical procedures, medical and psychosocial outcomes, and economic factors will ultimately lead to the development of rational recommendations for clinical care.
The LABS will also support clinical studies, as proposed, designed, and approved by the Steering Committee (see below), which will answer questions regarding impact of surgical procedures on important clinical outcomes. These may include the impact of bariatric surgery on insulin resistance and resolution of type 2 diabetes, or mechanisms by which bariatric surgery may enhance long-term weight maintenance. Other studies may use bariatric surgery as a model to better understand the causes of and potential treatments for obesity. For example, examining the impact of restrictive versus malabsorptive surgical procedures on hormones presumed to affect appetite may provide insights that will lead to new, non-surgical treatments of obesity that mimic the appetite-suppressive effects of surgery. A repository of data and biological specimens for future research also will be collected by the centers participating in LABS. These will provide valuable resources for future study of obesity and its complications.
Through a competitive, peer-reviewed process, six clinical centers and a data coordinating center were funded in September, 2003. The principal investigators are listed below. A steering committee, which is the governing body of the consortium, composed of the principal investigators at the clinical centers and data coordinating center as well as the NIH project coordinator, is meeting on a frequent basis during the initial year of funding to develop the database and plan the clinical protocols. In addition to the principal investigators, scientists and clinicians from the participating centers with relevant expertise are participating in ongoing committees and working groups. The Clinical Centers, Data Coordinating Center, and NIH are working together to develop common clinical protocols. It is anticipated that LABS will conduct one or more multi-center studies per year during its five-year funding period, ranging from small pilot studies to larger studies.
Funding for LABS, a five year project, was awarded to the clinical centers and data coordinating center in September, 2003. During the first year, investigators are working together to develop the protocols and to obtain appropriate human subjects approvals. The core database will be also be developed and implemented during the first year. It is anticipated that the first participants will be enrolled in the LABS database in the fall of 2004. Short-term and longer-term studies will occur during years 2-4, with continued follow-up and study analysis during the final year.
LABS is funded at $3,000,000 per year for five years. There are also opportunities for investigators to apply for additional funding for ancillary studies through a request for applications (RFA). Information on the ancillary studies RFA can be found at: http://grants.nih.gov/grants/guide/rfa-files/RFA-DK-03-022.html
LABS is not funded to provide patient care costs, including surgical costs, for participants enrolling in studies, although any tests or examinations done for research purposes (meaning not part of standard clinical care) will be free of charge to participants. Study participants will need to have other means, such as medical insurance or self-pay, for their surgery and related patient-care costs. Participant enrollment is expected to begin in the fall or 2004.
LABS may provide the preliminary data needed for future investigator-initiated research about bariatric surgery and obesity. For example, LABS investigators might explore metabolic and endocrine changes with bariatric surgery, generating information to allow researchers to submit separate applications for full-scale clinical studies. LABS may also encourage researchers to study the causes and treatments of obesity and its related health problems by providing access to laboratory specimens and tissues. Information on the types of data being included in the LABS database will be made available on its website, so that other interested clinicians and researchers can collect similar types of data on their patients, facilitating additional research on bariatric surgery. The presence of coordinated obesity research efforts at participating institutions may also provide opportunities for research and clinical training to students in the health professions, as well as to young investigators.
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