Natural Killer (NK) Cells Following Bariatric Surgery

The Natural Killer Cells Regulatory Role Against Hepatic Fibrosis Following Bariatric Surgery

This study will determine the role of the NK cells before and after bariatric surgery. The investigators selected patients with NAFLD.

A Fibroscan evaluation will be assessed as a new modality to evaluate liver fibrosis.

Study Overview

• Status: Unknown
• Conditions: Natural Killer Cell Deficiency, Familial Isolated
• Intervention / Treatment: Procedure: sleeve gastrectomy , roux-en-y gastric bypass

Detailed Description

All morbidly obese patients who are candidates for a bariatric procedure in the investigators institution who has a fatty liver in their routine preoperative US will undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the spectrometry (FACS) analysis.

The investigators will also collect other clinical data including comorbidities (hypertension, diabetes mellitus and hyperlipidemia) in addition to the following routine blood test( complete blood count, creatinine, urea, International normalized ratio, liver function test, HBa1C, cholesterol, HDL, LDL, triglycerides, vitamin D, vitamin B12, potassium, sodium, albumin, bilirubin, C- reactive protein, iron, ferritin and transferrin).

All of the above mentioned tests including the NK cells and the fibroscan will be examined for all participants in 3, 6, 12 months postoperatively.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Israel
  • Jerusalem 91120, Israel, 12000
    • Hadassah Medical Organization,Jerusalem,Israel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

obese patient with BMI above 30 with comorbidity or BMI above 35 with or without comorbidity, that have evidence of hepatic fibrosis on the routine preoperative US

Description

Inclusion Criteria:

• age from 18-65
• body mass index above 30 with comorbidity or above 35 with or without comorbidity
• evidence of hepatic fibrosis in routine preoperative US

Exclusion Criteria:

• patient with known other liver disease such as autoimmune or alcoholic hepatitis
• patient that take hepatotoxic medication or hormonal treatment
• active alcohol abuse above 20 gram per day
• Drug abuse
• patient refusal
• pregnancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery	NK cells are through to play role in modulating fibrogenesis. They exert an anti-fibrotic effects by Killing activated hepatic stellate Cells; the major cells responsible for fibrosis. NK cells activations are crucial step in inhibiting liver fibrosis. Therefore, their functions are thought to be affected in Obese patients. Our aim is to investigate changes in peripheral Blood NK cells by detecting their cytotoxicity potentials by CD107a (LAMP-1; Lysosomal-associated membrane protein 1) as a marker for activation and analyze them by flow-cytometry. Peripheral Blood NK cells will be obtained from obese patients prior to Bariatric surgery and following 3 months, 6 months and 12 months of the surgery.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the fibrosis downstaging by fibroscan prior and following Bariatric surgery	The liver fibrosis can be assess by fibroscan and scored from 0 to 4 . all the participants will be assessed by fibroscan prior an 3,6,12 month postoperative to determine the degree of down staging of liver fibrosis	1 year

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization
• Investigators: Principal Investigator: Abed Khalaileh, MD, PhD, israel ministrty of health

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (ANTICIPATED): August 1, 2017
• Study Completion (ANTICIPATED): December 1, 2017

Study Registration Dates

• First Submitted: December 2, 2015
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (ESTIMATE): April 8, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 14, 2016
• Last Update Submitted That Met QC Criteria: April 13, 2016
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Marrow Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Myelodysplastic Syndromes; GATA2 Deficiency
• Other Study ID Numbers: 0298-15-HMO-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED