Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Trial will test whether surgery is the best option for type 2 diabetes

11.02.2011
Study compares gastric bypass to conventional medical treatments and lifestyle modifications in mildly obese and non-obese patients

A new clinical trial at NewYork-Presbyterian Hospital/Weill Cornell Medical Center is among the first to test surgery specifically for Type 2 diabetes. The aim of the study is to understand whether surgery can control diabetes, as well or even better than the best medical treatment available today. This is the first study of its kind open to patients who are overweight or mildly obese.

Under current guidelines, bariatric surgery is only indicated for the treatment of severe or morbid obesity, defined as having a body mass index (BMI) of 35 or greater. By contrast, the new study is open to patients with a BMI as low as 26. Normal-weight individuals have BMI ranging between 19 and 25 and overweight individuals have BMI between 26 and 29, whereas a BMI above 30 defines obesity. Patients with a BMI below 26 and above 35 will not be considered for enrollment in the trial.

Previous research has shown that in severely obese patients (BMI greater than 35) gastric bypass surgery is a safe and effective way to treat Type 2 diabetes. It has been shown to improve or normalize blood glucose levels, reduce or even eliminate the need for medication, and lower the risk for diabetes-related death.

"There is preliminary evidence suggesting that that these results are attainable even in overweight or mildly-obese patients," says Dr. Francesco Rubino, chief of the gastrointestinal metabolic surgery program at NewYork-Presbyterian Hospital/Weill Cornell Medical Center and associate professor of surgery at Weill Cornell Medical College.

In support of this belief, recommendations from the American Diabetes Association's January 2009 issue of Standards of Care: Diabetes Care, and from the Diabetes Surgery Summit Consensus Conference, published in the March 2010 issue Annals of Surgery, suggest that randomized clinical trials for the study of surgery in patients with BMI below 35 are priority for diabetes research.

"Having a potentially effective surgical option against diabetes does not mean that surgery is the best choice for every diabetic patient," Dr. Rubino adds. "We need rigorous, comparative clinical trials, like this one, in order to better understand when to prioritize surgery and when to recommend traditional medical treatment."

The new study is enrolling 50 patients with Type 2 diabetes who will be randomized to receive surgery -- specifically, Roux-en-Y Gastric Bypass -- or traditional medical therapy and intensive lifestyle modification. All patients will be counseled in lifestyle modification techniques like diet and exercise.

Dr. Rubino expects that there will be medical advantages for patients in both arms of the trial since those assigned to the medical arm will receive the most rigorous medical diabetes therapy available. A multidisciplinary team of diabetes and nutrition experts will take care of patients using the most current, approved drugs for diabetes as well as an intensive approach to lifestyle changes. Patients in the medical arm will also be offered the chance to switch study arms and have surgery free of charge after the study is complete, or earlier should their diabetes remain poorly controlled after medical and lifestyle therapy.

Beyond BMI

Dr. Rubino and his co-investigators believe their study may also help identify better criteria than BMI for selection of surgical candidates. "Using strictly BMI-based criteria may be practical, but it is medically inappropriate because, on its own. BMI does not accurately define the severity of diabetes or identify patients who are best suited to benefit from a surgical approach," says Dr. Rubino. "New criteria would not only help patients and clinicians, but also payers."

Because insurers use BMI-based criteria, bariatric surgery is currently not covered for patients with a BMI less than 35, regardless of the severity of their disease. Consequently, the study at NewYork-Presbyterian/Weill Cornell is supported by a research grant from Covidien covering the cost of surgery for patients enrolled in the study.

A Look at How Diabetes Surgery Works

Previous research by Dr. Rubino studied how bariatric surgery alleviates diabetes, showing that the effect on diabetes is not entirely explained by a person's weight loss. In fact, the gastrointestinal tract serves as an endocrine organ and a key player in the regulation of insulin secretion, body weight and appetite, which is why altering the GI tract has such profound metabolic effects.

The current study aims to shed more light on the mechanisms of action of gastric bypass on diabetes. To do this, Dr. Rubino and his co-investigators will measure gut hormone responses to meal stimulation when an equivalent amount of weight loss has been achieved in both surgically and conventionally treated patients. This design may help uncover endocrine effects specific to gastric bypass surgery beyond those associated with non-surgical weight loss. "Understanding how gastric bypass surgery functions may help us learn how diabetes works," Dr. Rubino says. "This knowledge has the potential to lead to the development of new minimally invasive procedures, devices interventions and better pharmaceutical treatments."

Toward an International Consortium

Dr. Rubino hopes that the current study will be a template for larger, international studies. "We intend this study to serve as a core protocol for similar randomized clinical trials independently run at other institutions as part of a worldwide consortium coordinated through the Diabetes Surgery Center at NewYork-Presbyterian/Weill Cornell," he says. "The consortium will provide a larger pool of patients allowing researchers to better evaluate the impact of surgery on various health measures, including cardiovascular risk and life expectancy."

The global prevalence of Type 2 diabetes is rising dramatically. "If proven successful, diabetes surgery has the potential to help millions of patients in the U.S. and worldwide," Dr Rubino says.

According to International Diabetes Federation (IDF), there are currently 285 million people with the disease around the world, a number that is expected to rise to 438 million by 2030. Diabetes is one of the greatest public health threats in the 21st century and a risk factor for vascular damage and eye, kidney and cardiovascular diseases, as well as death. Type 2 diabetes results from inadequate insulin production and action, and is associated with metabolic dysfunctions involving lipid metabolism and blood pressure regulation.

Interested patients with Type 2 diabetes may contact the Diabetes Surgery Center at NewYork-Presbyterian/Weill Cornell at (212) 746-5925 or ant2026@med.cornell.edu.

NewYork-Presbyterian Hospital/Weill Cornell Medical Center

NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances -- including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson's disease; the first indication of bone marrow's critical role in tumor growth; and, most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit www.nyp.org and weill.cornell.edu

Andrew Klein | EurekAlert!
Further information:
http://weill.cornell.edu

More articles from Health and Medicine:

nachricht Researchers release the brakes on the immune system
18.10.2017 | Rheinische Friedrich-Wilhelms-Universität Bonn

nachricht Norovirus evades immune system by hiding out in rare gut cells
12.10.2017 | University of Pennsylvania School of Medicine

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Neutron star merger directly observed for the first time

University of Maryland researchers contribute to historic detection of gravitational waves and light created by event

On August 17, 2017, at 12:41:04 UTC, scientists made the first direct observation of a merger between two neutron stars--the dense, collapsed cores that remain...

Im Focus: Breaking: the first light from two neutron stars merging

Seven new papers describe the first-ever detection of light from a gravitational wave source. The event, caused by two neutron stars colliding and merging together, was dubbed GW170817 because it sent ripples through space-time that reached Earth on 2017 August 17. Around the world, hundreds of excited astronomers mobilized quickly and were able to observe the event using numerous telescopes, providing a wealth of new data.

Previous detections of gravitational waves have all involved the merger of two black holes, a feat that won the 2017 Nobel Prize in Physics earlier this month....

Im Focus: Smart sensors for efficient processes

Material defects in end products can quickly result in failures in many areas of industry, and have a massive impact on the safe use of their products. This is why, in the field of quality assurance, intelligent, nondestructive sensor systems play a key role. They allow testing components and parts in a rapid and cost-efficient manner without destroying the actual product or changing its surface. Experts from the Fraunhofer IZFP in Saarbrücken will be presenting two exhibits at the Blechexpo in Stuttgart from 7–10 November 2017 that allow fast, reliable, and automated characterization of materials and detection of defects (Hall 5, Booth 5306).

When quality testing uses time-consuming destructive test methods, it can result in enormous costs due to damaging or destroying the products. And given that...

Im Focus: Cold molecules on collision course

Using a new cooling technique MPQ scientists succeed at observing collisions in a dense beam of cold and slow dipolar molecules.

How do chemical reactions proceed at extremely low temperatures? The answer requires the investigation of molecular samples that are cold, dense, and slow at...

Im Focus: Shrinking the proton again!

Scientists from the Max Planck Institute of Quantum Optics, using high precision laser spectroscopy of atomic hydrogen, confirm the surprisingly small value of the proton radius determined from muonic hydrogen.

It was one of the breakthroughs of the year 2010: Laser spectroscopy of muonic hydrogen resulted in a value for the proton charge radius that was significantly...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

ASEAN Member States discuss the future role of renewable energy

17.10.2017 | Event News

World Health Summit 2017: International experts set the course for the future of Global Health

10.10.2017 | Event News

Climate Engineering Conference 2017 Opens in Berlin

10.10.2017 | Event News

 
Latest News

Electrode materials from the microwave oven

19.10.2017 | Materials Sciences

New material for digital memories of the future

19.10.2017 | Materials Sciences

Physics boosts artificial intelligence methods

19.10.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>