Metabolomic Fingerprint After Bariatric Surgery

NCT ID: NCT02480322

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Sleeve group

Patients undergoing gastric sleeve resection.

bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)

Intervention Type PROCEDURE

Proximal RYGB group

Patients undergoing proximal gastric bypass surgery.

bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)

Intervention Type PROCEDURE

Distal RYGB group

Patients undergoing distal gastric bypass surgery.

bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)

Intervention Type PROCEDURE

BMI-matched control group

No interventions assigned to this group

Normal-weight control group

No interventions assigned to this group

Interventions

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bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florence

OTHER

Sponsor Role collaborator

FiorGen Foundation, Italy

UNKNOWN

Sponsor Role collaborator

eSwiss Medical & Surgical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type DERIVED
PMID: 26581381 (View on PubMed)

Other Identifiers

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Metab-001

Identifier Type: -

Identifier Source: org_study_id

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