Metabolomic Fingerprint After Bariatric Surgery
Metabolomic Fingerprint of Severe Obesity is Dynamically Affected by Bariatric Surgery in a Procedure-dependent Manner
1 other identifier
observational
106
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 22, 2015
CompletedFirst Posted
Study publicly available on registry
June 24, 2015
CompletedJune 25, 2015
June 1, 2015
2 years
June 22, 2015
June 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
compare the NMR metabolic fingerprint as assessed in serum samples of severely obese patients with that of normal-weight control subjects
pre operative
follow up changes in the metabolic fingerprint over one year after 3 distinct bariatric procedures
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
12 months post operative
Study Arms (5)
Sleeve group
Patients undergoing gastric sleeve resection.
Proximal RYGB group
Patients undergoing proximal gastric bypass surgery.
Distal RYGB group
Patients undergoing distal gastric bypass surgery.
BMI-matched control group
Normal-weight control group
Interventions
Eligibility Criteria
severely obese patients of the Interdisciplinary Obesity Center, St. Gallen, Switzerland
You may qualify if:
- BMI \>/=35 kg/m2
- at least 2 years of unsuccessful conservative weight loss attempts
You may not qualify if:
- \< 18 years of age
- BMI \< 35 kg/m2
- informed consent was not signed by the patient
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- eSwiss Medical & Surgical Centerlead
- University of Florencecollaborator
- FiorGen Foundation, Italycollaborator
Related Publications (1)
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.
PMID: 26581381DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2015
First Posted
June 24, 2015
Study Start
May 1, 2010
Primary Completion
May 1, 2012
Last Updated
June 25, 2015
Record last verified: 2015-06