Obesity, MorbidNCT03391401
Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery
An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by St. Franziskus Hospital at 2 sites in Germany.
Trial summary
Morbid obesity leads to non-alcoholic fatty liver disease (NAFLD), and not all NAFLD cases benefit from weight loss e.g. after bariatric surgery. Our aim is to find out, which intrahepatic factors and / or biomarkers might be beneficial or can be identified as prognostic factors for remission of NAFLD after weight… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Morbid, Bariatric Surgery Candidate, NAFLD
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 204 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Mar 2018to 31 Jul 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Patients with the above given criteria that are willing to treat their morbid obesity by bariatric surgery and have at least absolved 3 months of failed conservative treatment for morbid obesity, have shown to have good long-time compliance and high motivation.
Who may be able to join
- BMI above 40 kg/sqm or
- BMI above 35 kg/sqm and comorbidities related to morbid obesity (e.g. type 2 diabetes, hypertension, coronary heart disease, dyslipoproteinemia, sleep apnea, and others
Who cannot join
- BMI below 35 kg/sqm
- no informed consent
- patient not suitable for bariatric surgery (severe psychological disorder, pregnancy, drug abuse, active malignant or other consuming disease
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
University of Bonn
Bonn, 53127
St. Franziskus-Hospital
Cologne, 50825
About this study
Morbid obesity leads to non-alcoholic fatty liver disease (NAFLD), and not all NAFLD cases benefit from weight loss e.g. after bariatric surgery. Our aim is to find out, which intrahepatic factors and / or biomarkers might be beneficial or can be identified as prognostic factors for remission of NAFLD after weight loss. As other factors such as the microbiome or muscle and fatty tissue also influence the development of obesity and liver diseases, it is planned to examine these parameters before and after bariatric surgery as well.
Tissue biopsies will therefore be taken during the surgery, and blood as well as stool samples will be collected and compared for suitable biomarkers before and after the intervention.
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate, NAFLD, Microbiome
- Being tested
- Bariatric surgery
- Medical subject headings
- Obesity, Morbid, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Any bariatric operation that is considered as a standard procedure in bariatric surgery (i.e. sleeve gastrectomy, roux-en-y gastric bypass, mini-gastric / one anastomosis gastric bypass, redo and revisional bariatric surgery).
| Study group | Role | What they receive |
|---|---|---|
| Adip1 | Patients with morbid obesity (i.e. BMI >35 kg/sqm) and age >18 scheduled for bariatric surgery (all standard procedures included) Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of microbiome after bariatric surgery
Collection of stool sample before and after (3 and 6 months) the operation
Measured: at time of operation, 3 and 6 months after the operation
Changes of microbiome after bariatric surgery
Collection of blood sample before and after (3 and 6 months) the operation
Measured: at time of operation, 3 and 6 months after the operation
Secondary outcomes (1)
incidence of fatty liver in obese patients
Surgical liver biopsy during laparoscopy
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Mar 2018
- Primary completion31 Jan 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bonn
- Responsible party
- Principal investigator, Andreas Plamper, St. Franziskus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391401
- Sponsor's protocol ID
- 2017110
- Status last verified
- Oct 2021
- First submitted
- 7 Dec 2017
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Z, Bowerman S, Heber D. Health ramifications of the obesity epidemic. Surg Clin North Am. 2005 Aug;85(4):681-701, v. doi: 10.1016/j.suc.2005.04.006.
PubMed 16061080Reeves GK, Pirie K, Beral V, Green J, Spencer E, Bull D; Million Women Study Collaboration. Cancer incidence and mortality in relation to body mass index in the Million Women Study: cohort study. BMJ. 2007 Dec 1;335(7630):1134. doi: 10.1136/bmj.39367.495995.AE. Epub 2007 Nov 6.
PubMed 17986716Sjostrom L, Peltonen M, Jacobson P, Sjostrom CD, Karason K, Wedel H, Ahlin S, Anveden A, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lonroth H, Narbro K, Naslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914.
PubMed 22215166Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
PubMed 24042449Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
PubMed 15479938Henao-Mejia J, Elinav E, Jin C, Hao L, Mehal WZ, Strowig T, Thaiss CA, Kau AL, Eisenbarth SC, Jurczak MJ, Camporez JP, Shulman GI, Gordon JI, Hoffman HM, Flavell RA. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 Feb 1;482(7384):179-85. doi: 10.1038/nature10809.
PubMed 22297845Fujisaka S, Ussar S, Clish C, Devkota S, Dreyfuss JM, Sakaguchi M, Soto M, Konishi M, Softic S, Altindis E, Li N, Gerber G, Bry L, Kahn CR. Antibiotic effects on gut microbiota and metabolism are host dependent. J Clin Invest. 2016 Dec 1;126(12):4430-4443. doi: 10.1172/JCI86674. Epub 2016 Oct 24.
PubMed 27775551Mathis D. Immunological goings-on in visceral adipose tissue. Cell Metab. 2013 Jun 4;17(6):851-859. doi: 10.1016/j.cmet.2013.05.008.
PubMed 23747244
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Microbiome-based Prognostical Biomarkers in Patients With Morbid Obesity and Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03391401
- Acronym / sponsor ID
- 2017110
- Conditions
- Obesity, Morbid, Bariatric Surgery Candidate, NAFLD, Microbiome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Collaborators
- University of Bonn
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 5 Jan 2018 (actual)
- 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.
Morbid obesity leads to non-alcoholic fatty liver disease (NAFLD), and not all NAFLD cases benefit from weight loss e.g. after bariatric surgery. Our aim is to find out, which intrahepatic factors and / or biomarkers might be beneficial or can be identified as prognostic factors for remission of NAFLD after weight loss. As other factors such as the microbiome or muscle and fatty tissue also influence the development of obesity and liver diseases, it is planned to examine these parameters before and after bariatric surgery as well.
Tissue biopsies will therefore be taken during the surgery, and blood as well as stool samples will be collected and compared for suitable biomarkers before and after the intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adip1 | – | Procedure: Bariatric surgeryPatients with morbid obesity (i.e. BMI >35 kg/sqm) and age >18 scheduled for bariatric surgery (all standard procedures included) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Patients with the above given criteria that are willing to treat their morbid obesity by bariatric surgery and have at least absolved 3 months of failed conservative treatment for morbid obesity, have shown to have good long-time compliance and high motivation.
Key inclusion criteria (2 listed)
- BMI above 40 kg/sqm or
- BMI above 35 kg/sqm and comorbidities related to morbid obesity (e.g. type 2 diabetes, hypertension, coronary heart disease, dyslipoproteinemia, sleep apnea, and others
Key exclusion criteria (3 listed)
- BMI below 35 kg/sqm
- no informed consent
- patient not suitable for bariatric surgery (severe psychological disorder, pregnancy, drug abuse, active malignant or other consuming disease
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 |
|---|---|---|
| Bariatric surgeryAny bariatric operation that is considered as a standard procedure in bariatric surgery (i.e. sleeve gastrectomy, roux-en-y gastric bypass, mini-gastric / one anastomosis gastric bypass, redo and revisional bariatric surgery). | Procedure or surgery | Adip1 |
Primary outcome
Changes of microbiome after bariatric surgery
Time frame: at time of operation, 3 and 6 months after the operation
Collection of stool sample before and after (3 and 6 months) the operation
Changes of microbiome after bariatric surgery
Time frame: at time of operation, 3 and 6 months after the operation
Collection of blood sample before and after (3 and 6 months) the operation
1 secondary outcome
incidence of fatty liver in obese patients
Time frame: during the operation
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 7 Oct 2021.
- Results publication: PubMed 16061080Li Z, Bowerman S, Heber D. Health ramifications of the obesity epidemic. Surg Clin North Am. 2005 Aug;85(4):681-701, v. doi: 10.1016/j.suc.2005.04.006.
- Results publication: PubMed 17986716Reeves GK, Pirie K, Beral V, Green J, Spencer E, Bull D; Million Women Study Collaboration. Cancer incidence and mortality in relation to body mass index in the Million Women Study: cohort study. BMJ. 2007 Dec 1;335(7630):1134. doi: 10.1136/bmj.39367.495995.AE. Epub 2007 Nov 6.
- Results publication: PubMed 22215166Sjostrom L, Peltonen M, Jacobson P, Sjostrom CD, Karason K, Wedel H, Ahlin S, Anveden A, Bengtsson C, Bergmark G, Bouchard C, Carlsson B, Dahlgren S, Karlsson J, Lindroos AK, Lonroth H, Narbro K, Naslund I, Olbers T, Svensson PA, Carlsson LM. Bariatric surgery and long-term cardiovascular events. JAMA. 2012 Jan 4;307(1):56-65. doi: 10.1001/jama.2011.1914.
- Results publication: PubMed 24042449Loomba R, Sanyal AJ. The global NAFLD epidemic. Nat Rev Gastroenterol Hepatol. 2013 Nov;10(11):686-90. doi: 10.1038/nrgastro.2013.171. Epub 2013 Sep 17.
- Results publication: PubMed 15479938Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and meta-analysis. JAMA. 2004 Oct 13;292(14):1724-37. doi: 10.1001/jama.292.14.1724.
- Results publication: PubMed 22297845Henao-Mejia J, Elinav E, Jin C, Hao L, Mehal WZ, Strowig T, Thaiss CA, Kau AL, Eisenbarth SC, Jurczak MJ, Camporez JP, Shulman GI, Gordon JI, Hoffman HM, Flavell RA. Inflammasome-mediated dysbiosis regulates progression of NAFLD and obesity. Nature. 2012 Feb 1;482(7384):179-85. doi: 10.1038/nature10809.
- Results publication: PubMed 27775551Fujisaka S, Ussar S, Clish C, Devkota S, Dreyfuss JM, Sakaguchi M, Soto M, Konishi M, Softic S, Altindis E, Li N, Gerber G, Bry L, Kahn CR. Antibiotic effects on gut microbiota and metabolism are host dependent. J Clin Invest. 2016 Dec 1;126(12):4430-4443. doi: 10.1172/JCI86674. Epub 2016 Oct 24.
- Results publication: PubMed 23747244Mathis D. Immunological goings-on in visceral adipose tissue. Cell Metab. 2013 Jun 4;17(6):851-859. doi: 10.1016/j.cmet.2013.05.008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid and Bariatric Surgery Candidate, run by St. Franziskus Hospital at 2 sites in Germany.
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 2 inclusion and 3 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 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
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?
Changes of microbiome after bariatric surgery (time frame: at time of operation, 3 and 6 months after the operation). The study lists 2 primary outcomes in all. 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 NCT03391401, which also lists 8 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 7 Oct 2021.