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
Nicole Frickman, 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
Nicole Frickman, CRA
Comparison of Serum Hyaluronic Acid Levels and Fibroscan with Histological Evaluations of Liver Fibrosis in Patients with Persistently Abnormal Liver Function Tests
The invasiveness of liver biopsy coupled with its problem of sampling error has received renewed attention has spurred researchers to seek alternative methods of evaluating liver fibrosis. A new noninvasive device known as the FibroScan has been clinically tested in Europe and found to objectively measure liver stiffness and the severity of hepatic fibrosis and is not affected by abdominal body fat. While it is widely used in Europe, the FibroScan device is not yet Food and Drug Administration (FDA)-approved in the U.S. and is considered an investigational device.
We are investigating the FibroScan device as a noninvasive alternative to liver biopsy for staging liver damage and to potentially avoid the need for repeated liver biopsies for patients in the future. A blood sample will also be drawn and will be used to look at biomarkers that may potentially determine the degree of liver injury or fibrosis. These experimental procedures will be compared to liver biopsy.
For more information please email
Nezam Afdhal, MD or
Nicole Frickman, CRA.
A Multicenter, Randomized, Double-Masked, Placebo-controlled Phase II Study to Assess the Safety and Efficacy of a Standardized Orally Administered Silymarin Preparation (Legalon®) for the Treatment of Non-Cirrhotic Patients with Non-Alcoholic Steatohepatitis (IND 74,887)
Silymarin, also known as milk thistle, is an alternative medicine commonly found in health food and vitamin stores but its purity is uncertain since herbal preparations are not registered by the Food and Drug Administration (FDA). While it is touted for its liver-protective effects, there is no clear data on its benefits in people with Non-alcoholic steatoheaptitis (NASH) and other liver diseases.
We are investigating the efficacy and safety of different doses of a highly purified oral preparation of silymarin in patients with varying severity of Non alcoholic fatty Liver disease (NAFLD) This is a double-blinded placebo-controlled trial where patients will be randomized to the investigational silymarin or placebo.
For more information please email
Nezam Afdhal, MD or
Joseph P. Colagreco, MS, NP.
The Effect of Fasting on Nonalcoholic Fatty Liver Disease
People with nonalcoholic fatty liver disease have excess fat stored in the liver. We recently discovered that people with NAFLD also have elevated levels of a protein called fibroblast growth factor 21 (FGF21). We are investigating whether FGF21 levels in the blood correlate with the amount of fat in the liver.
This study will investigate the effect of a single 72-hour fast on FGF21 levels and the amount of fat stored in the liver. We will use MRI to measure the amount of fat in the liver before and after the 72-hour fasting period. All participants will have a blood test and an MRI of the liver before and after the fasting period. Participants will be given the results of the MRI and will be paid for taking part in the study.
For more information, please email
Jody Dushay, MD.
The Effect of a Low-Calorie Diet on Nonalcoholic Fatty Liver Disease
Weight loss is known to be an effective treatment for nonalcoholic fatty liver disease (NAFLD), but it is not known how much less fat is in the liver after a period of weight loss.
This study will investigate the effect of a hypocaloric (low-calorie) diet on the amount of fat stored in the liver and on levels of a protein called fibroblast growth factor 21 (FGF21), which can be measured in the blood. We will use MRI to measure the amount of fat in the liver before and after the dieting period. All participants will have a blood test and an MRI of the liver before and after the dieting period. Study participants will be required to come to the Clinical Research Center at the Beth Israel Deaconess Medical Center approximately once a week for brief outpatient study visits. The target weight loss is 7-10% of initial body weight. Participants will be paid for taking part in the study. We will also provide all food during the dieting period and parking vouchers for study visits.
For more information, please email
Jody Dushay, MD.
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.