Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Body Weight
  • NAFLD
  • Non.Alcoholic Fatty Liver Disease
  • Nonalcoholic Steatohepatitis
  • Obesity
  • Weight Loss
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 22 years and 65 years
Gender
Both males and females

Description

Obesity:In adults, obesity is defined as a BMI of greater than 30 kg/m2. It is estimated that, by the year 2030, 38% of the world's adult population will be overweight and another 20% obese.An expert panel convened by the NIH stated that for the first time in history, the steadily improving worldwid...

Obesity:In adults, obesity is defined as a BMI of greater than 30 kg/m2. It is estimated that, by the year 2030, 38% of the world's adult population will be overweight and another 20% obese.An expert panel convened by the NIH stated that for the first time in history, the steadily improving worldwide life expectancy could level off or even decline, as the result of increasing obesity. NAFLD and NASH: The Problem: Obesity is a chronic disease that is strongly associated with a number of diseases with an increase in mortality and morbidity. Metabolic syndrome (obesity, diabetes mellitus, hyperlipidemia) has been established as risk factor for primary nonalcoholic fatty liver disease (NAFLD) .In the US, recent estimates suggest that NAFLD affects 30% of the general population, 90% of the morbidly obese . NAFLD can progress to nonalcoholic steatohepatitis (NASH) in up to 25% . Of patients with NASH progression of fibrosis is seen in 26-37% and progressing to cirrhosis in 9-25 % . NASH cirrhosis can result in liver failure, portal hypertension, and hepatocellular carcinoma(HCC) . Current options in management of NASH: The goal of managing NASH is to eliminate risk factors and preventing fibrosis by treating metabolic syndrome, primarily obesity [10]. Although dietary modification and exercise can achieve weight loss, this is difficult to sustain . Very few effective medical therapies are available, and are associated with adverse effects. Although weight loss after bariatric surgery has demonstrated histological improvement in NASH, a recent Cochrane review concluded that there is insufficient data to determine if bariatric surgery is an effective treatment. Also high mortality rates are seen post-bariatric surgery. Thus a safe and effective minimally invasive option is needed. Based on currently available data, Left gastric artery embolization (LGAE) appears effective in inducing weight loss of about 10.5% in 3-6 months, with a high safety profile. In patients with NAFLD, a 3-5% weight loss is thought to improve steatosis, 7- 10% may be needed to improve necroinflammation. Thus, LGAE has the potential to reverse the histology of NASH to prevent progression to cirrhosis, HCC and its sequale.

Tracking Information

NCT #
NCT02933554
Collaborators
Not Provided
Investigators
Principal Investigator: Keith Pereira, MD Assistant professor of radiology-Interventional radiology Principal Investigator: Brent Neuschwander-Tetri, MD Professor of medicine- gastroenterology Principal Investigator: Kirubahara Vaheesan, MD Assistant professor of radiology- Interventional radiology