Natural Killer Cell Deficiency, Familial IsolatedNCT02732535
Natural Killer (NK) Cells Following Bariatric Surgery
An observational study of Natural Killer Cell Deficiency, Familial Isolated, run by Hadassah Medical Organization at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Natural Killer Cell Deficiency, Familial Isolated
- What is being tested?
- sleeve gastrectomy , roux-en-y gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2015to Dec 2017
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hadassah Medical Organization,Jerusalem,Israel
Jerusalem, Israel, 12000
About this study
Official title: 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.
Read the 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.
- Being tested
- sleeve gastrectomy , roux-en-y gastric bypass
- Medical subject headings
- Natural Killer Cell Deficiency, Familial Isolated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve gastrectomy , roux-en-y gastric bypassProcedure or surgery
laparoscopic sleeve gastrectomy or laparoscopic gastric bypass
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Natural Killer Cell Deficiency, Familial IsolatedStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abed Khalaileh, MD, PhD, Principal investigator, israel ministrty of health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732535
- Sponsor's protocol ID
- 0298-15-HMO-CTIL
- Status last verified
- Oct 2015
- First submitted
- 2 Dec 2015
- Last updated
- 14 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Natural Killer Cells Regulatory Role Against Hepatic Fibrosis Following Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02732535
- Acronym / sponsor ID
- 0298-15-HMO-CTIL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 8 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sleeve gastrectomy , roux-en-y gastric bypasslaparoscopic sleeve gastrectomy or laparoscopic gastric bypass | Procedure or surgery | – |
Primary outcome
Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery
Time frame: 1 year
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 secondary outcome
To assess the fibrosis downstaging by fibroscan prior and following Bariatric surgery
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abed Khalaileh, MD, PhD principal investigator
israel ministrty of health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Natural Killer Cell Deficiency, Familial Isolated, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine Natural Killer (NK) cell phenotype and alterations prior and following Bariatric surgery (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2016.