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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A01226-39 | Other Identifier | IDRCB |
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Endoscopic sleeve gastroplasty and bypass are currently available for weight loss in obese patients who have failed nutritional management. Despite very low risks, these techniques remain invasive. What's more, the French National Authority for Health recommends this procedure for patients with a BMI above 35 kg/m² with associated co-morbidities, or above 40 kg/m². This excludes grade I obese patients (30 < BMI < 35) who have no effective means of losing weight. The hospital's hepato-gastroenterology and nutrition department has therefore implemented endoscopic sleeve gastroplasty to address this problem. As with other surgical techniques, there is heterogeneity heterogeneity in weight loss. The investigators therefore aim to identify factors predictive of the efficacy of this procedure in order to improve patient management of patients.
The prevalence of obesity is increasing worldwide, and it is estimated that one quarter of the world's population will be overweight or obese by 2045. Obesity can lead to complications, including cardiovascular damage (myocardial ischemia and stroke), liver damage (non-alcoholic steatohepatitis and liver cancer), diabetes and extra-hepatic cancers. In this context, achievement of a significant long-term weight loss is of paramount importance to ameliorate patient outcome. Bariatric surgery is the most effective treatment for severe obesity and results in a significant long-term weight loss. However, bariatric surgery is restricted to patients with a BMI >40 kg/m2 or >35 kg/m2 with commodities (hypertension, diabetes, sleep apnoea, NASH). Therefore, the majority of obese patients do not benefit from this procedure. Recent advances in flexible endoluminal endoscopy now provide the tools for transoral endoscopic gastric volume reduction (ESG, endoscopic sleeve gastroplasty).
The gastric body is reduced by an endoscopic procedure involving suture plications. This minimally invasive method may be a good therapeutic option to obtain a significant weight reduction in patients with moderate obesity or those with severe obesity and no indication for bariatric surgery (BMI between 35 and 40 kg/m2 without commodities). In this context this study aims to identify predictive factors of weight loss following ESG and explore changes of metabolic parameters, metabolomic profiles and gut microbiota profiles. This is a retro-prospective cohort study including patients with moderate obesity undergoing ECG between March 2017 and September 2023. Clinical parameters (weight, high, BMI, weight fluctuations), serum metabolic parameters (standard lipid profile, lipoprotein levels, fasting plasma glucose, insulin levels, C-peptide levels, hemoglobin A1c) and liver function test parameters (standard biology, transient elastometry, Fibrotest®, Actitest®, abdominal ultrasound) are systematically collected for all patients before ESG and then at three- and twelve-month post-ESG. Samples of serum, plasma, stools and saliva are also systematically collected for research purpose before ESG and then at three- and twelve-month post-ESG. Each sample is stored at -80°C for subsequent analysis. Metabolomic/lipidomic analysis will be used to quantify metabolite and lipid species in serum/plasma samples. Metagenomic analysis will be used to characterise faecal and salivary microbiota profiles.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bloed-, ontlasting- en speekselmonsters | Diagnostic Test | In addition, the blood collected (24 mL) will be used for the following analyses: GLP-1, PYY, branched-chain amino acids, Adipokines, leptin, adiponectin Blood bile acid levels: total and detailed analyzed by HPLC MS/MS Serum microbiome profile Genome-wide association study. The stool sample will be used to establish the : Intestinal bile acid profile Intestinal microbiota profile Saliva sampling for oral microbiota profiling. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum metabolite profile using widely targeted metabolomics according to weigh loss amount (less than 10% of total weight versus more than 10% of total weight loss at 12 months post-surgery) | A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics mass spectrometry. | Before endoscopic sleeve gastroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical parameters at baseline and then at 3 and 12 month post-intervention. | Weight expressed in kg, percentage of total weight loss and percentage of excessed weight loss will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Major grade I obese patients (BMI between 30 and 35 kg/m²) not eligible for sleeve gastrectomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cosmin VOICAN, MD, PhD | Contact | 1 45 37 47 75 | +33 | cosmin.voican@aphp.fr |
| Gabriel PERLEMUTER, MD, PhD | Contact | 1 45 37 47 75 | +33 | gabriel.perlemuter@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Cosmin VOICAN, MD, PhD | APHP, Antoine-Béclère Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Antoine Béclère | Recruiting | Paris | France |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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Samples (blood, plasmatheque, serotheque, stool) taken as part of the research will be will be collected in a biological collection. 12 mL blood on dry tube, 12 mL on EDTA tube, for a total of 24 mL of blood, will be collected at each research visit. 5 aliquots of serum and 5 aliquots of plasma of 0.5 mL will be kept. An aliquot of 1 mL of whole blood will be stored. 10 aliquots of approximately 2 mL of stool. 1 saliva swab of saliva will be collected and stored.
These collections will be kept at the biochemistry and bacteriology laboratory of the Antoine Béclère hospital, for a period of 30 years. At the end of the research, the samples may be used for further analyses not provided for in the protocol, which may prove to be of interest. that may be of interest in the context of obesity pathology, depending on the obesity, in line with the development of scientific knowledge, subject to the patient's informed, as indicated in the information/consent form.
| Basic serum lipid profile at baseline and then at 3 and 12 month post-intervention. |
Basic serum lipid profile will be analysed by spectrometry as they are systematically available in usual clinical practice. |
| Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Glycated hemoglobin at baseline and then at 3 and 12 month post-intervention. | Glycated hemoglobin expressed in % will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Insulin at baseline and then at 3 and 12 month post-intervention. | Insulin expressed in mUI/l will be analysed as it is systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| C peptide at baseline and then at 3 and 12 month post-intervention. | C peptide expressed in µg/l will be analysed as it is systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Ferritin at baseline and then at 3 and 12 month post-intervention. | Ferritin expressed in µg/l will be analysed as it is systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Liver function test parameter Alanine transaminase (ALT) at baseline and then at 3 and 12 month post-intervention. | ALT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Liver function test parameter aspartate transaminase (AST) at baseline and then at 3 and 12 month post-intervention. | AST levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Liver function test parameter Gamma-glutamyltransferase (GGT) at baseline and then at 3 and 12 month post-intervention. | GGT levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Liver function test parameter Alkaline phosphatase (ALP) at baseline and then at 3 and 12 month post-intervention. | ALP levels expressed in IU/l will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Liver fibrosis assessed by transient elastometry at baseline and then at 3 and 12 month post-intervention | Transient elastometry expressed in kPa will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Liver steatosis assessed by controlled attenuation parameter (CAP) at baseline and then at 3 and 12 month post-intervention. | Controlled attenuation parameter expressed in dB/m will be analysed as they are systematically available in usual clinical practice. | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Serum metabolites using widely targeted metabolomics at baseline and then at 3 and 12 month post-intervention. | A volume of 50 µl of serum/plasma will be used for analysis of serum metabolites using widely targeted metabolomics by mass spectrometry | Change from baseline (before endoscopic sleeve gastroplasty) to Month 3 and Month 12 |
| Complications of endoscopic sleeve gastroplasty | Data on the potential complications (occurrence of perforation, bleeding, peritonitis and other infections, thrombo-embolic events and death) of endoscopic sleeve gastroplasty will be collected. | During the first week post-endoscopic sleeve gastroplasty and at Month 3 and Month 12 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |