Ignite Creation Date:
2025-12-24 @ 10:38 PM
Ignite Modification Date:
2026-02-28 @ 10:52 PM
Study NCT ID:
NCT02732535
Status:
UNKNOWN
Last Update Posted:
2016-04-14
First Post:
2015-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Killer (NK) Cells Following Bariatric Surgery
Sponsor:
Hadassah Medical Organization
Organization:
Study Overview
Official Title:
The Natural Killer Cells Regulatory Role Against Hepatic Fibrosis Following Bariatric Surgery
Status:
UNKNOWN
Status Verified Date:
2015-10
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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undergo a fibroscan to assess the degree of liver fibrosis preoperatively in addition to a blood sample that will be withdrawn from those participants to isolate the NK cells and to assess their activities by the assessment of the active form of NK cells (CD107a) using the spectrometry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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: