Metabolomic Fingerprint After Bariatric Surgery

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sleeve group<br>Patients undergoing gastric sleeve resection. | Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)<br> <br> |
| Proximal RYGB group<br>Patients undergoing proximal gastric bypass surgery. | Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)<br> <br> |
| Distal RYGB group<br>Patients undergoing distal gastric bypass surgery. | Procedure: bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)<br> <br> |
| BMI-matched control group<br> | |
| Normal-weight control group<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metabolic alterations