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Natural Killer (NK) Cells Following Bariatric Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02732535
Enrollment
40
Registered
2016-04-08
Start date
2015-08-31
Completion date
2017-12-31
Last updated
2016-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Natural Killer Cell Deficiency, Familial Isolated

Brief 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.

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undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the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

Interventions

PROCEDUREsleeve gastrectomy , roux-en-y gastric bypass

laparoscopic sleeve gastrectomy or laparoscopic gastric bypass

Sponsors

Hadassah Medical Organization
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery1 yearNK 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.

Secondary

MeasureTime frameDescription
To assess the fibrosis downstaging by fibroscan prior and following Bariatric surgery1 yearThe 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

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026