Metabolomic Fingerprint After Bariatric Surgery

June 24, 2015 updated by: eSwiss Medical & Surgical Center

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

severely obese patients of the Interdisciplinary Obesity Center, St. Gallen, Switzerland

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
12 months post operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

eSwiss Medical & Surgical Center

Collaborators

University of Florence
FiorGen Foundation, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

June 22, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 24, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Metab-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe