Natural Killer (NK) Cells Following Bariatric Surgery

Natural Killer Cell Deficiency, Familial Isolated Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02732535
• Other study ID #: 0298-15-HMO-CTIL
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 2, 2015
• Last updated: April 13, 2016
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: October 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the spectrometry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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Natural Killer Cell Deficiency, Familial Isolated

Intervention

Procedure:
• sleeve gastrectomy , roux-en-y gastric bypass
laparoscopic sleeve gastrectomy or laparoscopic gastric bypass

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization,Jerusalem,Israel	Jerusalem 91120

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes