Metabolic SyndromeNCT02641925
Omentectomy for Metabolic Syndrome in Gastric Cancer Patients
A study testing Omentum preserving and Total omentectomy in people with Metabolic Syndrome and Gastric Cancer, run by Keimyung University Dongsan Medical Center at 3 sites in South Korea.
Trial summary
Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Metabolic Syndrome, Gastric Cancer
- What is being tested?
- Omentum preserving and Total omentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Aug 2015to Aug 2020
- Phase
- Interventional
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed adenocarcinoma in stomach
- Aged≥20 years and ≤80 years
- Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0)
- Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria
- ECOG 0 (Eastern Cooperative Oncology Group)
- ASA score class I-III (American Society of Anesthesiologists)
- patient has given their written informed consent to participate in the study
Who cannot join
- Simultaneously combined resection of other organ
- Active other malignancy
- Expected to severe intra-abdominal adhesion due to previous abdominal operation history
- Uncontrolled co-morbidity
- Vulnerable patients
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Dong-A University Hospital
Busan, 602-715
Min Chan Kim, MD, PhD
Min Chan Kim, MD, PhD
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 700-712
Seung Wan Ryu, MD, PhD, 82-53-250-7322, gsman@dsmc.or.kr
In Gyu Kwon, MD, 82-53-250-7322, surgeon@dsmc.or.kr
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do, 519-809
Young Kyu Park, MD, PhD
Seong Yeop Ryu, MD, PhD
About this study
Official title: The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)
Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.
Read the detailed description
The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.
- Conditions
- Metabolic Syndrome, Gastric Cancer
- Being tested
- Omentum preserving, Total omentectomy
- Keywords
- Metabolic syndrome, gastric cancer, omentectomy
- Medical subject headings
- Metabolic Syndrome, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omentum preservingProcedure or surgery
The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.
Total omentectomyProcedure or surgery
Whole omentum will be removed during gastrectomy with lymph node dissection.
| Study group | Role | What they receive |
|---|---|---|
| Omentum preserving | Active comparator | Omentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed. Receives: Procedure: Omentum preserving |
| Total omentectomy | Experimental | Total omentectomy: Whole omentum will be removed. Receives: Procedure: Total omentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HOMA-IR change
HOMA-IR change after operation
Measured: pre-operative and post-operative 12months
Secondary outcomes (3)
prevalence of metabolic syndrome
check the presence of metabolic syndrome
Measured: pre-operative and post-operative 12months
Complication
short-term any complication related to surgery
Measured: within 30days
HOMA-IR change according to anastomosis type
comparison between Billoth-II and Roux-en-Y
Measured: pre-operative and post-operative 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2019 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Chonnam National University Hospital, Dong-A University Hospital
- Responsible party
- Principal investigator, Seung Wan Ryu, Keimyung University Dongsan Medical Center
- Investigators
- Seung Wan Ryu, M.D., Ph.D., Principal investigator, Korean South West East Gastric Surgery Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641925
- Sponsor's protocol ID
- 2015-07-010
- Other IDs
- KSWEET-02
- Status last verified
- May 2017
- First submitted
- 24 Dec 2015
- Last updated
- 1 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
An JY, Kim YM, Yun MA, Jeon BH, Noh SH. Improvement of type 2 diabetes mellitus after gastric cancer surgery: short-term outcome analysis after gastrectomy. World J Gastroenterol. 2013 Dec 28;19(48):9410-7. doi: 10.3748/wjg.v19.i48.9410.
PubMed 24409070Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Baracat J, Geloneze B. Visceral fat resection in humans: effect on insulin sensitivity, beta-cell function, adipokines, and inflammatory markers. Obesity (Silver Spring). 2013 Mar;21(3):E182-9. doi: 10.1002/oby.20030.
PubMed 23404948Lottati M, Kolka CM, Stefanovski D, Kirkman EL, Bergman RN. Greater omentectomy improves insulin sensitivity in nonobese dogs. Obesity (Silver Spring). 2009 Apr;17(4):674-80. doi: 10.1038/oby.2008.642. Epub 2009 Feb 12.
PubMed 19214178Sdralis E, Argentou M, Mead N, Kehagias I, Alexandridis T, Kalfarentzos F. A prospective randomized study comparing patients with morbid obesity submitted to sleeve gastrectomy with or without omentectomy. Obes Surg. 2013 Jul;23(7):965-71. doi: 10.1007/s11695-013-0925-z.
PubMed 23526069Tchernof A, Despres JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011.
PubMed 23303913Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.
PubMed 11850750Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833.
PubMed 20587720
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Visceral Fat Removal for Gastric Cancer Patients With Metabolic Syndrome, Randomized Pilot Study: Omentectomy for Metabolic Syndrome (OMS)
- ClinicalTrials.gov ID
- NCT02641925
- Acronym / sponsor ID
- 2015-07-010
- Conditions
- Metabolic Syndrome, Gastric Cancer
- Keywords
- Metabolic syndrome, gastric cancer, omentectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Collaborators
- Chonnam National University Hospital, Dong-A University Hospital
- Study start
- Aug 2015
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 30 Dec 2015 (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.
Many features of the metabolic syndrome are associated with insulin resistance. And, metabolic syndrome and insulin resistance are related to visceral obesity. Therefore, the investigators hypothesized that visceral fat removal (omentectomy) can make favorable results for the insulin resistance and metabolic syndrome. As the omentectomy is optional procedure during a surgery for early gastric cancer, the investigators will divide patients randomly into two groups, total omentectomy group and omentum preserving group.
Detailed description
The investigators will compare the change of insulin resistance (HOMA-IR) and improvement of metabolic syndrome between total omentectomy and omentum preserving group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Omentum preserving | Active comparator | Procedure: Omentum preservingOmentum preserving: The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed. |
| Total omentectomy | Experimental | Procedure: Total omentectomyTotal omentectomy: Whole omentum will be removed. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed adenocarcinoma in stomach
- Aged≥20 years and ≤80 years
- Scheduled as laparoscopic distal gastrectomy (cT1N0M0 or cT2N0M0)
- Metabolic syndrome (NCEP:ATP III (National Cholesterol Education Program and Adult Treatment Panel III) -harmonizing definition criteria
- ECOG 0 (Eastern Cooperative Oncology Group)
Key exclusion criteria (5 listed)
- Simultaneously combined resection of other organ
- Active other malignancy
- Expected to severe intra-abdominal adhesion due to previous abdominal operation history
- Uncontrolled co-morbidity
- Vulnerable patients
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 |
|---|---|---|
| Omentum preservingThe minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection. | Procedure or surgery | Omentum preserving |
| Total omentectomyWhole omentum will be removed during gastrectomy with lymph node dissection. | Procedure or surgery | Total omentectomy |
Primary outcome
HOMA-IR change
Time frame: pre-operative and post-operative 12months
HOMA-IR change after operation
3 secondary outcomes
prevalence of metabolic syndrome
Time frame: pre-operative and post-operative 12months
Complication
Time frame: within 30days
HOMA-IR change according to anastomosis type
Time frame: pre-operative and post-operative 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2017.
- Background: PubMed 24409070An JY, Kim YM, Yun MA, Jeon BH, Noh SH. Improvement of type 2 diabetes mellitus after gastric cancer surgery: short-term outcome analysis after gastrectomy. World J Gastroenterol. 2013 Dec 28;19(48):9410-7. doi: 10.3748/wjg.v19.i48.9410.
- Background: PubMed 23404948Lima MM, Pareja JC, Alegre SM, Geloneze SR, Kahn SE, Astiarraga BD, Chaim EA, Baracat J, Geloneze B. Visceral fat resection in humans: effect on insulin sensitivity, beta-cell function, adipokines, and inflammatory markers. Obesity (Silver Spring). 2013 Mar;21(3):E182-9. doi: 10.1002/oby.20030.
- Background: PubMed 19214178Lottati M, Kolka CM, Stefanovski D, Kirkman EL, Bergman RN. Greater omentectomy improves insulin sensitivity in nonobese dogs. Obesity (Silver Spring). 2009 Apr;17(4):674-80. doi: 10.1038/oby.2008.642. Epub 2009 Feb 12.
- Background: PubMed 23526069Sdralis E, Argentou M, Mead N, Kehagias I, Alexandridis T, Kalfarentzos F. A prospective randomized study comparing patients with morbid obesity submitted to sleeve gastrectomy with or without omentectomy. Obes Surg. 2013 Jul;23(7):965-71. doi: 10.1007/s11695-013-0925-z.
- Background: PubMed 23303913Tchernof A, Despres JP. Pathophysiology of human visceral obesity: an update. Physiol Rev. 2013 Jan;93(1):359-404. doi: 10.1152/physrev.00033.2011.
- Background: PubMed 11850750Thorne A, Lonnqvist F, Apelman J, Hellers G, Arner P. A pilot study of long-term effects of a novel obesity treatment: omentectomy in connection with adjustable gastric banding. Int J Obes Relat Metab Disord. 2002 Feb;26(2):193-9. doi: 10.1038/sj.ijo.0801871.
- Background: PubMed 20587720Herrera MF, Pantoja JP, Velazquez-Fernandez D, Cabiedes J, Aguilar-Salinas C, Garcia-Garcia E, Rivas A, Villeda C, Hernandez-Ramirez DF, Davila A, Zarain A. Potential additional effect of omentectomy on metabolic syndrome, acute-phase reactants, and inflammatory mediators in grade III obese patients undergoing laparoscopic Roux-en-Y gastric bypass: a randomized trial. Diabetes Care. 2010 Jul;33(7):1413-8. doi: 10.2337/dc09-1833.
- Individual participant dataSharing planned: Yes
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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.
Seung Wan Ryu, M.D., Ph.D. principal investigator
Korean South West East Gastric Surgery Group
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omentum preserving and Total omentectomy in people with Metabolic Syndrome and Gastric Cancer, run by Keimyung University Dongsan Medical Center at 3 sites in South Korea.
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 7 inclusion and 5 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 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Contact Seung Wan Ryu, M.D., Ph.D. (82-53-250-7322, gsman@dsmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HOMA-IR change (time frame: pre-operative and post-operative 12months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641925, which also lists 7 linked publications.
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 1 Jun 2017; AzTrials last refreshed its copy on 8 Nov 2026.