Transient Elastography of the Liver ( Fibroscan ) and Bariatric Surgery

NCT02122263 | Unknown

• 1 other identifier: 0007-14-ZIV
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of Bariatric surgery on the extent of liver fat and liver fibrosis and on different metabolic parameters in patients undergoing sleeve gastrectomy surgery.

Conditions

NAFLD

Outcome Measures

Primary Outcomes (1)

• Transient elastography

  6 month after baseline

Study Arms (1)

NAFLD after sleeve gastrectomy surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

60 obese NAFLD patients after sleeve gastrectomy surgery

You may qualify if:

• Subjects 18-65 years old
• BMI \> 40 kg/m² or BMI \> 35 kg/m² with comorbidities
• Willingness to take a metformin once a day for 6 months
• Ultrasound diagnosed NAFLD patients
• Reading and speaking Hebrew

You may not qualify if:

• Subject with mental illness or cognitive deterioration
• Use of probiotic/antibiotic 3 mounts before surgery
• Use of other antibiotic for more than 1 week during the study
• Drug addiction
• Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
• Treatment with drugs known to cause hepatic steatosis or elevation of liver enzymes (e.g. Corticosteroids, HAART, Amiodarone, high dose estrogens)
• Treatment with drugs or supplements that may improve hepatic steatosis or liver enzymes (Vitamin E, Milk thistle, ω-3 fatty acid, Ursodeoxycholic acid) 3 months prior to the initiation of the study
• Other causes of chronic liver disease ( e.g. viral hepatitis: HBV/HCV +, autoimmune hepatitis, Hemochromatosis, Wilson's disease)
• Diabetic patients who are treated with antidiabetic medications, except diabetic patients who are treated for at least 6 months exclusively with Metformin at a stable dose
• Subjects who began a new lipid reduction medications less than 6 months prior to the initiation of the study
• Subjects with chronic conditions that could interfere with our study: active cancer, organ transplant subjects, advanced kidney or liver disease, inflammatory bowel disease and other systemic inflammatory conditions
• Bariatric surgery in the past

Sponsors & Collaborators

• Ziv Hospital: lead

Study Sites (1)

ZIv Medical Center

Safed, Israel, 13100, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Nimer Assy, Prof

  Ziv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nimer Assy, MD

CONTACT

972-4-6828442; assy.n@ziv.health.gov.il

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor

Study Record Dates

• First Submitted: March 20, 2014
• First Posted: April 24, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 24, 2014

Record last verified: 2014-04

Locations

IL (1)