NCT01828528

Brief Summary

The purpose of this study is to investigate the effect of weight loss rate on liver steatosis, steatohepatitis, fibrosis and cardiovascular risk at different stages before and after bariatric surgery. The investigators also aim to study the short-term effect of bariatric surgery on gastric cholecystokinin levels before and 10 days after the bariatric surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 10, 2013

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

3.3 years

First QC Date

April 3, 2013

Last Update Submit

November 23, 2016

Conditions

Nonalcoholic Fatty Liver DiseaseNonalcoholic Steatohepatitis

Keywords

Nonalcoholic fatty liver diseaseNonalcoholic steatohepatitisObesityBariatric surgeryWeight loss

Outcome Measures

Primary Outcomes (1)

  • Change from baseline liver steatosis, steatohepatitis and fibrosis at different stages after bariatric surgery, measured by non-invasive measurements as described below.

    Measurements to be performed to assess liver disease stage at baseline and at 8-12 days and 12, 24 and 48 weeks after surgery: 1. Blood tests of liver functions (Alanine transaminase, Aspartate transaminase, Alkaline Phosphatase, gamma-glutamyl transpeptidase, ferritin, prothrombin-time (PT), international normalized ratio (INR), Total/Direct Bilirubin, Albumin, uric acid), lipids profile (total cholesterol, triglycerides, HDL, LDL) and diabetes biomarkers (insulin, glucose, HbA1c). 2. Blood tests of adiponectin (only at baseline and 48 weeks after surgery). 3. Fibroscan test for quantifying liver fibrosis by means of elastography (only at baseline and 48 weeks after surgery). 4. A blood test (FibroMax) for determining the stage and grade of liver damage (only at baseline and at 24 and 48 weeks after surgery). 5. OWLiver® test (a serum based test that can discriminate NAFLD from steatohepatitis using metabolomics) at baseline and 48 weeks after surgery.

    Baseline is defined as three weeks to one month before surgery. Different stages to compare to baseline are as following: 8-12 days and 12, 24 and 48 weeks after surgery.

Secondary Outcomes (2)

  • Change of postoperative cardiovascular risk compared to baseline.

    Baseline is defined as three weeks to one month before surgery. Change will be assessed 6-12 months after surgery.

  • Change in cholecystokinin levels before and after the surgery.

    Baseline levels of cholecystokinin at 1-2 days before surgery compared to 8-12 days after surgery.

Study Arms (1)

NAFLD after SG

26 patients with NAFLD undergoing sleeve gastrectomy (SG).

Procedure: Sleeve gastrectomy

Interventions

Sleeve gastrectomyPROCEDURE

An intra-operative liver biopsy was performed in 20 patients

NAFLD after SG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

26 diabetic patients with NAFLD (diagnosed by ultra sound) undergoing sleeve gastrectomy (SG) at Surgery C department at Sheba Medical Center, Israel.

You may qualify if:

  • ≤ age ≤80
  • BMI\>35kg/m2
  • Men and women
  • Fatty infiltration in liver ultrasonography

You may not qualify if:

  • Alcohol drinking \> 140g/week
  • Presence of hepatitis B or C or HIV
  • Known liver disease such as:
  • Wilson's disease
  • hemochromatosis
  • α1-antitrypsin deficiency
  • autoimmune liver disease
  • primary biliary cirrhosis
  • primary sclerosing cholangitis)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liver Disease Center, Sheba Medical Center, Tel-Hashomer

Ramat Gan, 52621, Israel

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, Liver tissue

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseObesityWeight Loss

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Officials

  • Ziv Ben-Ari, Prof

    Director Liver Disease Center, Sheba Medical Center, Tel-Hashomer, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2013

First Posted

April 10, 2013

Study Start

April 1, 2013

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

IL(1)