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Clinical Research Trials

Nonalcoholic Fatty Liver Disease (NAFLD) Patient Registry

One of the many consequences of the obesity epidemic facing the United States and other developed countries is the increased prevalence of NAFLD. NAFLD includes a spectrum of disorders ranging from simple steatosis to NASH (Nonalcoholic steatohepatitis), with the possibility of progression to cirrhosis and liver cancer.

There is still much more to be known about these disorders. This prospective study will follow patients with NAFLD every 6 months, collecting clinical data, serum, whole blood, and tissue from patients with NAFLD. With these data, we hope to learn more about its natural history and risk factors for progression and to develop noninvasive tests to diagnose Nonalcoholic steatohepatitis (NASH), a more serious and progressive condition.

For more information please email Michelle Lai, MD, MPH or Angelica Francescucci,CRA

Safety, Efficacy and Long-term Outcomes of Bariatric Surgery in Obese Patients with Advanced Fibrosis (stage 3-4) from Nonalcoholic Steatosis (NASH) and/or Hepatitis C

Surgery is currently the most effective treatment for morbid obesity, resulting in significant weight loss and reduction in mortality rate due to improvements in the comorbid conditions of obesity.

In this study patients with advanced hepatic fibrosis (stage 3-4) and severe obesity (BMI>40 or BMI>35 with serious comorbid conditions- such as coronary heart disease and Type 2 Diabetes) will be evaluated before and after laparoscopic gastric banding surgery. Specifically, we will study the early and late effects of bariatric surgery in obese patients with advanced fibrosis from NASH and/or Hepatitis C, on clinical, pathological, and quality-of-life measures as well as portal pressures. All these measurements will be taken before and after surgery.

For more information please email Michelle Lai, MD, MPH or Angelica Francescucci,CRA

A Prospective Study of Patterns, Predictors, and Mechanisms of Weight Loss with Exenatide Treatment in Overweight and Obese Women without Diabetes

This study looks at the effects of a medication and/or a low-calorie diet on body weight and energy expenditure. The medication is called exenatide (brand name Byetta). Exenatide is an injectable medication that is approved by the FDA for the treatment of type 2 diabetes. It is not approved for the treatment of obesity. Exentide has shown to have several effects on the body including decreased hunger, and the slowing of gastric (stomach) emptying.
At all study visits, you will have weight, blood pressure, waist circumference, and body composition measured. You will also be asked to complete questionnaires about hunger, fullness and nausea. At some study visits, you will have blood drawn to measure markers of metabolism and inflammation. You may also be asked to have your energy expenditure measured at these study visits. Compensation will be provided for participating and subjects will receive a parking voucher at all study visits.

For more information, please email Jody Dushay, MD.

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 Steatohepatitis (NASH)

Weight loss from diet, exercise or surgical procedure is the only current strategy for alleviating the effects of Non-Alcoholic Steatohepatitis (NASH). This progressive condition creates fibrosis (or scarring) in the liver and can result in cirrhosis.

GS-6624 is an experimental study drug designed to potentially help reverse the scarring process. This study will investigate the effects GS-6624 has on the progression of liver fibrosis (or scarring) in those with NASH. This is a double-blind, placebo controlled study that will last two years.  Participants will be required to report to Beth Israel Deaconess Medical Center once a month in order to collect clinical data, blood samples and training on proper drug administration. Also, liver tissue samples will be collected three times a year for evaluation.

For more information please email Michelle Lai, MD, MPH or Angelica Francescucci, CRA.

Contact Information

Angelica Francescucci

Clinical Research Assistant

Beth Israel Deaconess Medical Center
Phone: 617-632-1068
Fax: 617-632-1125