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Metabolomic Fingerprint After Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT02480322
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : June 25, 2015
Sponsor:
Collaborators:
University of Florence
FiorGen Foundation, Italy
Information provided by (Responsible Party):
eSwiss Medical & Surgical Center

Study Description
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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.


Condition or disease Intervention/treatment
Obesity Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)

Study Design
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Study Type : Observational
Actual Enrollment : 106 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Metabolomic Fingerprint of Severe Obesity is Dynamically Affected by Bariatric Surgery in a Procedure-dependent Manner
Study Start Date : May 2010
Actual Primary Completion Date : May 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Sleeve group
Patients undergoing gastric sleeve resection.
 Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)
Proximal RYGB group
Patients undergoing proximal gastric bypass surgery.
 Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)
Distal RYGB group
Patients undergoing distal gastric bypass surgery.
 Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)
BMI-matched control group
Normal-weight control group


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
severely obese patients of the Interdisciplinary Obesity Center, St. Gallen, Switzerland
Criteria

Inclusion Criteria:

  • BMI >/=35 kg/m2
  • at least 2 years of unsuccessful conservative weight loss attempts

Exclusion Criteria:

  • < 18 years of age
  • BMI < 35 kg/m2
  • informed consent was not signed by the patient
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: eSwiss Medical & Surgical Center
ClinicalTrials.gov Identifier: NCT02480322    
Other Study ID Numbers: Metab-001
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: June 25, 2015
Last Verified: June 2015
Keywords provided by eSwiss Medical & Surgical Center:
metabolic alterations
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight