Metabolomic Fingerprint After Bariatric Surgery

Completed

• Conditions: Obesity
• Interventions: Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)

• Registration Number: NCT02480322
• Lead Sponsor: eSwiss Medical & Surgical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-05
• Status Verified: 2015-06
• Study First Submitted: 2015-06-22
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Last Update Submitted: 2015-06-24
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sleeve group	bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)	Patients undergoing gastric sleeve resection.
Proximal RYGB group	bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)	Patients undergoing proximal gastric bypass surgery.
Distal RYGB group	bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)	Patients undergoing distal gastric bypass surgery.

Primary Outcome Measures

Name	Time	Method
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