ObesityNCT02697695
Chronic Inflammation After Obesity Surgery
An observational study of Obesity, run by Sana Klinikum Offenbach.
Trial summary
To evaluate the impact of obesity surgery on chronic inflammation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laboratory Examination
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Feb 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent LSG, LRYGB, LOLGB due to obesity and/or metabolic syndrome
Who may be able to join
- BMI > 35kg/m² and obesity-related disease or BMI > 40kg/m²
Who cannot join
- acute inflammation during laboratory examination
About this study
Official title: Impact of Obesity and Metabolic Surgery on Chronic Inflammation
To evaluate the impact of obesity surgery on chronic inflammation.
Read the detailed description
A retrospective study to compare the impact of laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en Y- gastric bypass (LRYGB) and laparoscopic omega-loop gastric bypass (LOLGB) on chronic inflammation and metabolic syndrome.
- Conditions
- Obesity
- Being tested
- Laboratory Examination
- Keywords
- chronic inflammation, fatty liver index
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory ExaminationOther
Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic sleeve gastrectomy | patients who underwent laparoscopic sleeve gastrectomy (LSG) due to obesity and/or metabolic syndrome Receives: Other: Laboratory Examination | |
| laparoscopic Roux-en-Y- gastric bypass | patients who underwent laparoscopic Roux-en-Y- gastric bypass (LRYGB) due to obesity and/or metabolic syndrome Receives: Other: Laboratory Examination | |
| laparoscopic omega-loop gastric bypass | patients who underwent laparoscopic omega-loop gastric bypass (LOLGB) due to obesity and/or metabolic syndrome Receives: Other: Laboratory Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic inflammation
the changing of leucocytes in /nl after obesity surgery
Measured: one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively
Secondary outcomes (9)
Fatty liver index
the changing of fatty liver index after obesity surgery
Measured: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Liver enzymes
the changing of GOT in U/l, GPT in U/l, GGT in U/l, AP in U/l after obesity surgery
Measured: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Body Mass Index (BMI) in kg/m²
the changing of BMI in kg/m² before and after obesity surgery
Measured: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
weight in kg
the changing of weight before and after obesity surgery
Measured: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
waist circumference
the changing of waist circumference in cm before and after obesity surgery
Measured: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
HbA1c
the changing of HbA1c in % and after obesity surgery
Measured: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Chronic inflammation II
the changing of c-reactive protein in mg/l after obesity surgery
Measured: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Acute inflammation
the changing of c-reactive protein in mg/l after obesity surgery
Measured: one day preoperatively and one and four days postoperatively
Acute inflammation II
the changing of leucocytes in /nl after obesity surgery
Measured: one day preoperatively and one and four days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2016 (estimated)
- Study startOct 2014
- Primary completionDec 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Klinikum Offenbach
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sonja Chiappetta, MD, Sana Klinikum Offenbach
- Investigators
- Rudolf Weiner, MD, Study chair, Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02697695
- Sponsor's protocol ID
- FF 145/2015
- Status last verified
- Jul 2018
- First submitted
- 20 Feb 2016
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hotamisligil GS. Inflammation and metabolic disorders. Nature. 2006 Dec 14;444(7121):860-7. doi: 10.1038/nature05485.
PubMed 17167474Nijhuis J, Rensen SS, Slaats Y, van Dielen FM, Buurman WA, Greve JW. Neutrophil activation in morbid obesity, chronic activation of acute inflammation. Obesity (Silver Spring). 2009 Nov;17(11):2014-8. doi: 10.1038/oby.2009.113. Epub 2009 Apr 23.
PubMed 19390527Morshed G, Fathy SM. Impact of post-laparoscopic sleeve gastrectomy weight loss on C-reactive protein, lipid profile and CA-125 in morbidly obese women. Wideochir Inne Tech Maloinwazyjne. 2016 Jan;10(4):521-6. doi: 10.5114/wiitm.2015.56480. Epub 2015 Dec 15.
PubMed 26865887Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.
PubMed 15864338Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
PubMed 15599400Chiappetta S, Schaack HM, Wolnerhannsen B, Stier C, Squillante S, Weiner RA. The Impact of Obesity and Metabolic Surgery on Chronic Inflammation. Obes Surg. 2018 Oct;28(10):3028-3040. doi: 10.1007/s11695-018-3320-y.
PubMed 29876839
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Obesity and Metabolic Surgery on Chronic Inflammation
- ClinicalTrials.gov ID
- NCT02697695
- Acronym / sponsor ID
- FF 145/2015
- Conditions
- Obesity
- Keywords
- chronic inflammation, fatty liver index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Sana Klinikum OffenbachUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 3 Mar 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.
To evaluate the impact of obesity surgery on chronic inflammation.
Detailed description
A retrospective study to compare the impact of laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en Y- gastric bypass (LRYGB) and laparoscopic omega-loop gastric bypass (LOLGB) on chronic inflammation and metabolic syndrome.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| laparoscopic sleeve gastrectomy | – | Other: Laboratory Examinationpatients who underwent laparoscopic sleeve gastrectomy (LSG) due to obesity and/or metabolic syndrome |
| laparoscopic Roux-en-Y- gastric bypass | – | Other: Laboratory Examinationpatients who underwent laparoscopic Roux-en-Y- gastric bypass (LRYGB) due to obesity and/or metabolic syndrome |
| laparoscopic omega-loop gastric bypass | – | Other: Laboratory Examinationpatients who underwent laparoscopic omega-loop gastric bypass (LOLGB) due to obesity and/or metabolic syndrome |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent LSG, LRYGB, LOLGB due to obesity and/or metabolic syndrome
Key inclusion criteria (1 listed)
- BMI > 35kg/m² and obesity-related disease or BMI > 40kg/m²
Key exclusion criteria (1 listed)
- acute inflammation during laboratory examination
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 |
|---|---|---|
| Laboratory ExaminationLaboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB | Other | laparoscopic Roux-en-Y- gastric bypass, laparoscopic omega-loop gastric bypass, laparoscopic sleeve gastrectomy |
Primary outcome
Chronic inflammation
Time frame: one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively
the changing of leucocytes in /nl after obesity surgery
9 secondary outcomes
Fatty liver index
Time frame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Liver enzymes
Time frame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Body Mass Index (BMI) in kg/m²
Time frame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
weight in kg
Time frame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
waist circumference
Time frame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
HbA1c
Time frame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Chronic inflammation II
Time frame: one day preoperatively and 1 month, 3 month, 6 month and up to 12 month postoperatively
Acute inflammation
Time frame: one day preoperatively and one and four days postoperatively
Acute inflammation II
Time frame: one day preoperatively and one and four days postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2018.
- Results publication: PubMed 17167474Hotamisligil GS. Inflammation and metabolic disorders. Nature. 2006 Dec 14;444(7121):860-7. doi: 10.1038/nature05485.
- Results publication: PubMed 19390527Nijhuis J, Rensen SS, Slaats Y, van Dielen FM, Buurman WA, Greve JW. Neutrophil activation in morbid obesity, chronic activation of acute inflammation. Obesity (Silver Spring). 2009 Nov;17(11):2014-8. doi: 10.1038/oby.2009.113. Epub 2009 Apr 23.
- Results publication: PubMed 26865887Morshed G, Fathy SM. Impact of post-laparoscopic sleeve gastrectomy weight loss on C-reactive protein, lipid profile and CA-125 in morbidly obese women. Wideochir Inne Tech Maloinwazyjne. 2016 Jan;10(4):521-6. doi: 10.5114/wiitm.2015.56480. Epub 2015 Dec 15.
- Results publication: PubMed 15864338Wellen KE, Hotamisligil GS. Inflammation, stress, and diabetes. J Clin Invest. 2005 May;115(5):1111-9. doi: 10.1172/JCI25102.
- Results publication: PubMed 15599400Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625.
- Derived from this study: PubMed 29876839Chiappetta S, Schaack HM, Wolnerhannsen B, Stier C, Squillante S, Weiner RA. The Impact of Obesity and Metabolic Surgery on Chronic Inflammation. Obes Surg. 2018 Oct;28(10):3028-3040. doi: 10.1007/s11695-018-3320-y.
- Individual participant dataSharing planned: No
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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.
Rudolf Weiner, MD study chair
Sana Klinikum Offenbach, Department of Obesity and Metabolic Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Sana Klinikum Offenbach.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 31 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Chronic inflammation (time frame: one day preoperatively, and 1 month, 3 month, 6 month and up to 12 month postoperatively). 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 NCT02697695, which also lists 6 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 31 Jul 2018; AzTrials last refreshed its copy on 2 Nov 2026.