Metabolomic Fingerprint After Bariatric Surgery

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

Primary outcomes

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
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
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

Sponsors and collaborators

Lead sponsor

eSwiss Medical & Surgical Center

Other

Collaborators

FiorGen Foundation, Italy
University of Florence

Registry information

Official study title

Metabolomic Fingerprint of Severe Obesity is Dynamically Affected by Bariatric Surgery in a Procedure-dependent Manner

Important dates

Study start: 2010
Primary completion: 2012
First posted: Jun 24, 2015
Registry last updated: Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed