Current Research & Innovations

Obesity

• A Prospective Study To Evaluate The Safety, Efficacy and Outcomes Of Laparoscopic Adjustable Gastric Banding (LAGB) in Patients with BMI <40 —Obesity is the second largest cause of preventable death in the US after smoking. Successful therapy for obesity should be measured by the ability to achieve and maintain a clinically significant weight loss, by the beneficial effects of weight loss on co-morbidities, and the incidence and prevalence of complications. Current treatment options are diet, behavior modification, medication and surgery.
  
  Surgery remains the only proven long-term treatment for obesity. Among the surgical options, laparoscopic adjustable gastric banding (LAGB) is currently the most common bariatric surgical procedure worldwide. It has shown to yield satisfactory weight loss and has fewer life-threatening complications that total less than 1% and a mortality of 0.1%.
  
  The purpose of this study is to evaluate weight loss, change co-morbidity status and quality of life in patients who do not meet standard criteria for weight loss surgery and undergo LAGB. Please note that this is an unfunded study, therefore costs will not be covered by a research grant. (Marc Bessler, M.D.)
• Changes in Insulin Sensitivity, Gastrointestinal Hormones, Thyroid Hormones and Body Composition after Weight Loss induced by Bariatric Surgery or Caloric Restriction —The purpose of this study is to examine insulin sensitivity, gastrointestinal hormones, thyroid hormones and body composition before and after weight loss induced by gastric bypass surgery or gastric banding.
  
  There are 2 days of testing that include blood tests for hormones, insulin sensitivity testing and abdominal fat analysis by MRI
  
  Participant will receive financial compensation. (Judith Korner, MD)
• Diabetes Surgery Study (Global Randomized Prospective Study of Intensive Medical Management of Type 2 Diabetes, with and without Gastric Bypass Surgery) —Recently, some small studies have suggested that gastric bypass surgery may be useful in the treatment of diabetes and may be better than standard medical therapy (oral medications, insulin injections, etc) in the treatment of diabetes.
  
  The purpose of this study is to assess the short term effects of Roux-en-Y gastric bypass on type 2 diabetes and to determine whether intensive medical therapy or surgical therapy combined with intensive medical therapy is better in the treatment of patients with type 2 diabetes and moderate obesity. All study participants will receive comprehensive medical management of their diabetes including nutritional education for two years at no cost. If randomized to the surgical arm, costs also will be covered for the surgical procedure. (Judith Korner, MD)
• Effects of Obesity Surgery on Asthma —Obesity is associated with many illnesses, including asthma. It is known that obesity causes low-grade inflammation throughout the body. This inflammation may be important to the development of inflammation in the airway, leading to asthma.
  
  The purpose of this study is to determine if markers of asthma improve after weight loss following gastric-bypass surgery. This study will help determine if obesity plays a role in causing asthma.
  
  Participants will receive an evaluation of their lung function and allergy status. The study will also involve filling out questionnaires and providing breath and blood samples. (Marc Bessler, MD)
• Facilitated Fatty Acid Uptake In Obesity —The purpose of this study is to determine if fat tissue from obese persons has a greater capacity for fatty acid uptake than that of normal weight individuals.
  
  We would like to examine, in the laboratory, how your fat cells take up certain natural compounds called free fatty acids, which are then converted to fat. These fat samples will be for research purposes only, and will not interfere with your surgery or your recovery. The duration of your participation in this study will be the same duration as your surgery. (Paul Berk, M.D.)
• LABS Cognitive Effects of Bariatric Surgery Study —The purpose of this study is to learn more about body weight and brain function, by comparing cognitive function of people who do and do not undergo bariatric surgery.
  
  Study subjects will visit the clinic at the New York State Psychiatric Institute for an initial evaluation session. During the visit, they will be asked to complete cognitive functioning tests that are done on computer to assess things like memory, attention, and motor skills. Subjects will also be asked to complete questionnaires and answer questions about their backgrounds, medical history, psychiatric history. There are three follow-up visits at 12 weeks, 12 months, and 24 months after the initial visit.
  
  For each session subjects are paid $50, totaling up to $200 for the initial evaluation session and the three follow-up study sessions. Payment in the form of a check will be mailed approximately 4 to 6 weeks after completing a session. (Michael Devlin, M.D.)
• LABS-3 Psychosocial Issues and Bariatric Surgery Study —The purpose of the LABS-3 study is to learn more about patients undergoing bariatric surgery and to follow them over time to determine 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.
  
  Information about psychological history, eating behaviors and quality of life is collected in interviews, either by phone or in person. Participants will also be mailed two questionnaires with a self-addressed stamped envelope for easy return. After the participant’s surgery, some assessments will be re-administered at: 6 months, 1 year, 18 months, and 2 years after the surgery date. Again, these assessments can be completed over the phone or in person.
  
  Subjects who complete all assessments at all time points will receive a total of $110. Participants in an optional Eating Behavior Interview will receive an additional $80 (total: $190). A check will be mailed 4-6 weeks after each assessment point. Participants will be paid only for the follow-up sessions they complete. (Michael Devlin, M.D.)
• Leptin After Gastric Bypass —We are conducting a study using leptin in patients who have undergone Roux-en Y gastric bypass surgery. Leptin is a hormone produced by fat cells that leads to decreased food intake and weight loss when given to individuals that lack this hormone. We have found that leptin levels drop significantly in individuals who have had gastric bypass surgery. Such low levels of leptin may restrict your ability to lose more weight.
  
  The main purpose of this study is to determine if patients who have lost weight after gastric bypass will lose more weight when given leptin compared to when they are given placebo. As part of the study, you will also receive free nutritional counseling. (Judith Korner, M.D.)
• Longitudinal Assessment of Bariatric Surgery 2 (LABS 2) —The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) established a bariatric surgery research consortium, the Longitudinal Assessment of Bariatric Surgery (LABS), to help determine the risks and benefits of bariatric surgery. LABS is a consortium of six clinical centers and a Data Coordinating Center (DCC) working with the NIH to plan, develop and conduct clinical, epidemiological and behavioral research in the field. LABS-2 will enroll approximately 2,400 patients over 3 years.
  
  The goal of this study is to assess how well weight control surgery reduces your body weight and improves health conditions related to obesity. LABS 2 examines what types of patients do best after surgery and what kinds of treatment are most helpful. It also looks at longer term safety issues. The information on patient characteristics, surgical, medical and psychosocial outcomes and economic factors will ultimately lead to developing recommendations for clinical care. (Paul Berk, M.D.)
• TOGA™: Assessment of the Safety and Effectiveness of Transoral Gastroplasty in the Treatment of Morbid Obesity —The objective of the study is to determine the safety and effectiveness of the TOGa system for the treatment of morbid obesity. The device under investigation is referred to as the TOGa™ Transoral Gastroplasty Stapling System and is composed of the TOGa Sleeve Stapler and the TOGa Restrictor.
  
  A secondary objective is to determine the effect of the treatment on comorbidities and quality of life measures.
  
  Please go to www.togaclinicalstudy.com to learn more about the procedure and see if you qualify for the study. You will have the opportunity to enter your contact information and a member of our team will contact you within the next two weeks. (Marc Bessler, MD)