ObesityNCT02480322
Metabolomic Fingerprint After Bariatric Surgery
An observational study of Obesity, run by eSwiss Medical & Surgical Center.
Trial summary
Background: Obesity is associated with multiple diseases. Bariatric surgery is the most effective therapy for severe obesity that cannot only reduce body weight but also obesity-associated morbidity. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)
- Type of treatment
- Surgery or procedure
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- May 2010to May 2012
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: severely obese patients of the Interdisciplinary Obesity Center, St. Gallen, Switzerland
Who may be able to join
- BMI >/=35 kg/m2
- at least 2 years of unsuccessful conservative weight loss attempts
Who cannot join
- < 18 years of age
- BMI < 35 kg/m2
- informed consent was not signed by the patient
About this study
Official title: Metabolomic Fingerprint of Severe Obesity is Dynamically Affected by Bariatric Surgery in a Procedure-dependent Manner
Background: Obesity is associated with multiple diseases. Bariatric surgery is the most effective therapy for severe obesity that cannot only reduce body weight but also obesity-associated morbidity.
Objective: The metabolic alterations associated with obesity and respective changes after bariatric surgery are incompletely understood.
Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based global, untargeted metabolomics strategy on human serum samples that were collected before and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy, proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also analyzed serum samples from normal-weight and less obesity obese subjects that were matched for 1-year postoperative BMI values of the surgical groups.
- Conditions
- Obesity
- Being tested
- bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)
- Keywords
- metabolic alterations
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Sleeve group | Patients undergoing gastric sleeve resection. Receives: Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB) | |
| Proximal RYGB group | Patients undergoing proximal gastric bypass surgery. Receives: Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB) | |
| Distal RYGB group | Patients undergoing distal gastric bypass surgery. Receives: Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB) | |
| BMI-matched control group | Not described | |
| Normal-weight control group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare the NMR metabolic fingerprint as assessed in serum samples of severely obese patients with that of normal-weight control subjects
Measured: pre operative
follow up changes in the metabolic fingerprint over one year after 3 distinct bariatric procedures
Measured: pre operative, 3-, 6-, 9- and 12 months post operative
compare the metabolic fingerprints established one year after the different surgeries with those of BMI-matched and normal-weight control subjects
Measured: 12 months post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startMay 2010
- Primary completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- eSwiss Medical & Surgical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Florence, FiorGen Foundation, Italy
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480322
- Sponsor's protocol ID
- Metab-001
- Status last verified
- Jun 2015
- First submitted
- 22 Jun 2015
- Last updated
- 25 Jun 2015
- Results posted
- No
Publications
Gralka E, Luchinat C, Tenori L, Ernst B, Thurnheer M, Schultes B. Metabolomic fingerprint of severe obesity is dynamically affected by bariatric surgery in a procedure-dependent manner. Am J Clin Nutr. 2015 Dec;102(6):1313-22. doi: 10.3945/ajcn.115.110536. Epub 2015 Nov 18.
PubMed 26581381
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomic Fingerprint of Severe Obesity is Dynamically Affected by Bariatric Surgery in a Procedure-dependent Manner
- ClinicalTrials.gov ID
- NCT02480322
- Acronym / sponsor ID
- Metab-001
- Conditions
- Obesity
- Keywords
- metabolic alterations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- eSwiss Medical & Surgical CenterUniversity, hospital or other
- Collaborators
- University of Florence, FiorGen Foundation, Italy
- Study start
- May 2010
- Primary completion
- May 2012 (actual)
- First posted
- 24 Jun 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.
Background: Obesity is associated with multiple diseases. Bariatric surgery is the most effective therapy for severe obesity that cannot only reduce body weight but also obesity-associated morbidity.
Objective: The metabolic alterations associated with obesity and respective changes after bariatric surgery are incompletely understood.
Design: In the longitudinal observational study, the investigator applied a 1H-NMR-based global, untargeted metabolomics strategy on human serum samples that were collected before and repeatedly up to one year after distinct bariatric procedures (sleeve gastrectomy, proximal and distal Roux-en Y gastric bypass; RYGB). For comparison, the investigator also analyzed serum samples from normal-weight and less obesity obese subjects that were matched for 1-year postoperative BMI values of the surgical groups.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sleeve group | – | Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)Patients undergoing gastric sleeve resection. |
| Proximal RYGB group | – | Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)Patients undergoing proximal gastric bypass surgery. |
| Distal RYGB group | – | Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)Patients undergoing distal gastric bypass surgery. |
| BMI-matched control group | – | – |
| Normal-weight control group | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- severely obese patients of the Interdisciplinary Obesity Center, St. Gallen, Switzerland
Key inclusion criteria (2 listed)
- BMI >/=35 kg/m2
- at least 2 years of unsuccessful conservative weight loss attempts
Key exclusion criteria (3 listed)
- < 18 years of age
- BMI < 35 kg/m2
- informed consent was not signed by the patient
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 surgery (sleeve resection, proximal RYGB, distal RYGB) | Procedure or surgery | Distal RYGB group, Proximal RYGB group, Sleeve group |
Primary outcome
compare the NMR metabolic fingerprint as assessed in serum samples of severely obese patients with that of normal-weight control subjects
Time frame: pre operative
follow up changes in the metabolic fingerprint over one year after 3 distinct bariatric procedures
Time frame: pre operative, 3-, 6-, 9- and 12 months post operative
compare the metabolic fingerprints established one year after the different surgeries with those of BMI-matched and normal-weight control subjects
Time frame: 12 months post operative
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 25 Jun 2015.
- Derived from this study: PubMed 26581381Gralka E, Luchinat C, Tenori L, Ernst B, Thurnheer M, Schultes B. Metabolomic fingerprint of severe obesity is dynamically affected by bariatric surgery in a procedure-dependent manner. Am J Clin Nutr. 2015 Dec;102(6):1313-22. doi: 10.3945/ajcn.115.110536. Epub 2015 Nov 18.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by eSwiss Medical & Surgical Center.
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 25 Jun 2015. 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?
compare the NMR metabolic fingerprint as assessed in serum samples of severely obese patients with that of normal-weight control subjects (time frame: pre operative). The study lists 3 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 NCT02480322, which also lists 1 linked publication.
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 25 Jun 2015.