Research is a very important component of the comprehensive care we offer to our patients. Participating in research offers you the opportunity to help us learn more about obesity and improve treatment. Every patient who comes for a weight loss surgery consultation at the Weill Cornell Weight Loss Surgery Program will be invited to join our ongoing clinical trials. The Institutional Review Board of Weill Cornell Medical College has approved all research studies.

The following studies are OPEN to enrollment

1. Data Collection Project for Weight Loss Surgery (0502007736)

• PI: Dr. Pomp
• Investigators: Dr. Dakin, Dr. Strain, Costa, and Ebel

Aims:

• All patients who receive weight loss surgery are asked for their permission to use their data on basic demographics, type of surgery and possible complications prior to and following surgery for comparative purposes
• Nothing is required of the patient other than permission to use their information
• The purpose of this study is to learn more about how weight loss occurs with surgery, possible complications of surgery and how the different surgeries compare

2. Longitudinal Assessment of Weight Change after Sleeve Gastrectomy (1002010891)

• PI: Dr. Strain
• Supported by Weill Cornell Medical College
• Investigators: Drs. Pomp, Dakin, Saif, Ebel, Rossidis

Aims:

• Assessment of body weight /composition, quality of life, and nutritional status after sleeve gastrectomy as single procedure for surgical weight loss.

3. Clinical and Pathophysiologic Consequences of Bariatric Surgery (0704009103)

• PI: Dr. Pomp
• Supported by an NIH subcontract from Columbia
• Investigators: Dr. Dakin, Dr. Strain, Ebel, Costa

Aims:

• The purpose of this study is to learn more about body processes that might contribute to the development of obesity. Researchers will analyze body fat cells prior to surgery. If a second procedure is needed to augment the first procedure, fat samples will again be collected at time of surgery to understand the changes in body fat cells after significant weight loss
• If possible, cells from the liver will be examined to study the effects of excessive body fat on the liver and how the liver changes with weight loss
• Small fat samples will be taken during surgery

4. Facilitated Uptake of Long Chain Fatty Acids in Obesity (NIH DK052401)

• PI: Dr. Berk
• PI Cornell: Dr. Pomp
• Investigators: Dr. Dakin, Dr. Strain, Ebel, Costa

Aims:

• The purpose of this study is to learn more about body processes that might contribute to the development of obesity. Researchers are looking to determine whether the fat cells in obese subjects (50) are different from fat cells from non-obese subjects
• This study will examine in the laboratory how fat cells take up certain natural compounds called free fatty acids which are then converted to fat in both subject groups

5. Enterra Therapy Gastric Stimulation System (0803009686)

• PI: Dr. Dakin

Aims:

• The Enterra™ system is a device indicated for the treatment of patients with long term, uncontrolled (not helped by medication) nausea and vomiting from gastroparesis of diabetic or idiopathic origin
• This is not an ongoing clinical trial study but requires IRB approval as the FDA gave the Enterra system an approval of a Humanitarian Device Exemption (HDE) of a Humanitarian Use Device (HUD)

6. A Comparison of Caloric Restriction and Gastric Bypass on Glucose Homeostasis (0812010145)

• PI: Dr. Francesco Rubino
• Support: WCMC, Covidien, Medtronic
• Investigators: Drs: Pomp, Dakin, Strain, Sinha, Brillon, Morrison, and Chuck, Ebel, Costa

Aims:

• This research study is being conducted to increase the understanding of and identify the mechanisms by which blood sugar elevations improve rapidly for some bariatric surgery patients, often before significant weight loss has occurred
• This study will compare glucose homeostasis in subjects with diagnosed Type II diabetes (30) undergoing bariatric surgery either by being kept on a 5 day very low calorie diet (VLCD) before surgery, or after surgery. Subjects will be admitted to our research center
• This study will help to increase our understanding of the differences in glucose homeostasis obtained in subjects undergoing Roux-en-Y Gastric Bypass versus Gastric Banding or Sleeve Gastrectomy

7. Laparoscopic Gastric Bypass for Type 2 Diabetes Mellitus: A Pilot Prospective Study in Overweight and Mildly Obese Subjects (0906010450)

• PI: Dr. Rubino
• Support: WCMC and patient self pay
• Investigators: Dr. Pomp, Dr. Dakin, Dr. Strain, Dr. Sinha, Dr. Brillon, Chuck, Morrison, Ebel and Costa

Aims:

• In this pilot study, patients who are either overweight or mildly obese (i.e. with BMIs <35) who request Roux-en-Y Gastric Bypass as an assist to managing their diabetes are given surgery on a self-pay basis and followed for the resolution of their diabetes
• This research study is being conducted to increase the understanding of and identify the mechanisms by which blood sugar elevations improve rapidly for some bariatric surgery patients, often before significant weight loss has occurred.

8. Gastric Bypass Surgery Versus Intensive Medical Management in Achieving Glycemic Control in Diabetic Patients with BMI < 35 (1002010906)

• PI: Dr. Rubino
• Support: Covidien
• Investigators: Dr. Pomp, Dr. Dakin, Dr. Strain, Dr. Sinha, Dr. Brillon, Morrison, Tam, Ebel and Costa

Aims:

1) to investigate whether or not gastrointestinal surgery can control diabetes in overweight-to-moderately obese patients

2) to compare diabetes control after surgery with medical treatment of diabetes in overweight-to-moderately obese patients

3) to determine if clinical trials comparing medication and surgery can be performed with regard to randomizing groups and recruiting subjects.

9. Assessment of Post-operative GI Symptoms in Bariatric Surgery Patients (1104011630)

• PI: Dakin
• Support: WCMC
• Investigators: Pomp, Rubino, Costa, Ebel, Strain

Aims:

• Observe gastrointestinal symptoms directly after surgery.
• To compare gastrointestinal responses to the 4 surgical procedures.

The following studies are CLOSED to enrollment, but patients are still in follow-up. 9. NIDDK LABS Center (DK 03-006)

• PI: Paul Berk
• LABS 2, Longitudinal Assessment of Bariatric Surgery (LABS 2 #0508008060)
• PI (Weill Cornell): Dr. Alfons Pomp
• Investigators: Dr. Gladys Strain, Dr. Gregory Dakin, Mrs. Faith Ebel and Mr. Ricardo Costa

Aims:

• As a follow-up to the LABS 1 study previously completed which examined the 30 day mortality rate after bariatric procedures in 5000 patients, the LABS 2 study is a comprehensive longer term assessment of 2,400 patients. This protocol will assess the long-term effects of weight loss on health, gender issues, behavioral factors, work issues and leisure activities over 8 years.
• For more information on the LABS Consortium and their ongoing research go to: www.niddklabs.org

10. Body Composition and REE Responses to Bariatric Surgeries (NIH, DK 03-022 sub contract to Weill Cornell)

• PI: Dympna Gallagher, Ed.D
• PI: Dr. Strain, Weill Cornell (No Weill Cornell IRB approval required)
• Investigators: Drs. Pomp, Dakin, Ebel

Aims:

• Consenting patients (52) will undergo multiple studies prior to and following bariatric procedures of body composition in order to examine the changes that occur. Measurement include total intracellular and extracellular body water, skeletal muscle mass, organ sizes, and bone mineral content using dilution techniques, MRI, and dual energy-X-ray absorptiometry
• Screening only at Weill Cornell and referral to St. Lukes for consenting and studies. Dr. Strain, who was chairperson of the LABS BC work group, will liaison with the Body Composition Laboratory and be involved in patient follow-up, data analysis, and manuscript preparation.

11. Psychosocial Issues in Bariatric Surgery (0710009452)

• PI: Dr. Strain
• Investigators: Dr. Pomp, Dr. Dakin, Ebel

Aims:

• Patients will be asked to participate in telephone interviews conducted by Columbia University concerning psychosocial issues (LABS 3)
• The purpose is to learn more about patients undergoing bariatric surgery and to follow them over time. Specifically, we are trying to find out what types of psychological and eating behavior characteristics will have an impact on the long-term results of bariatric surgery. With this information we may be able to learn what kinds of treatment are most helpful for patients

12. Cognitive Effects of Bariatric Surgery (0711009535)

• PI: Dr. Strain
• Investigators: Dr. Pomp, Dr. Dakin, Ebel and Costa
• Supported by an NIH subcontract from Columbia

Aims:

• The purpose of this research study is to learn more about the cognitive functioning of patients (75 from Cornell; 150 worldwide) undergoing bariatric surgery and to follow them over time with standardized computerized testing
• Specifically, we are trying to find out if cognitive functioning, or aspects of how the brain works, including memory, concentration, language, intelligence, interpreting information from the senses, and coordinating physical movement, improves in people following bariatric surgery

Our Research Team

Please contact us with any questions you may have about our ongoing research and clinical trials listed above.

Gladys Strain, RD, PhD
Director of Research
Department of Surgery, Weight Loss Surgery Program

Email: gls2010@med.cornell.edu
Phone: (212) 746-5661
Fax: (212) 746-8680

Faith Ebel MPH, RD
Research Coordinator
Department of Surgery, Weight Loss Surgery Program

Email: fee2002@med.cornell.edu
Phone: (212) 746-5069
Fax: (212) 746-8680

Ricardo N. Costa
Research Coordinator
Department of Surgery, Weight Loss Surgery Program

Email: ric2012@med.cornell.edu
Phone: (212) 746-3310
Fax: (212) 746-8680