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Bariatric Surgery clinical trials

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NCT ID: NCT06391255 Not yet recruiting - Bariatric Surgery Clinical Trials

Reference Values for Gastric Emptying Scintigraphy After Bariatric Surgery

SCATTER
Start date: May 15, 2024
Phase:
Study type: Observational

Oesophageal and gastric scintigraphy evaluates the function of the gastrointestinal system including variables such as oesophageal transit and gastric emptying (GE). Some variables are known to change after bariatric surgery. In patients that have symptoms of pain or nausea after bariatric surgery, oesophageal and gastric scintigraphy plays an important role in determining the nature of symptoms and is necessary for adequate treatment. However, literature on reference values in the bariatric population are scarce. At this moment, quantitative evaluation of the scintigraphy cannot be performed and conclusions are based on visual interpretation. There is a need for a standardised scintigraphy protocol for the population that underwent bariatric surgery taking into account the changed anatomy and physiology. Then, reference values that describe the oesophageal transit and GE assessed using scintigraphy have to be determined.

NCT ID: NCT06294704 Not yet recruiting - Type 1 Diabetes Clinical Trials

Hybrid Closed Loop Insulin Pump and Bariatric Surgery in Patients With Type 1 Diabetes

PompBariatDT1
Start date: May 1, 2024
Phase:
Study type: Observational

Bariatric surgery is increasingly performed on patients with type 1 diabetes. It exposes these patients to an increased risk of hypoglycemia, including severe hypoglycemia, and of severe episodes of hyperglycemia, beyond the perioperative period. The long-term efficacy and safety of hybrid closed-loop insulin pump in these patients has not yet been published.

NCT ID: NCT06222151 Not yet recruiting - Physical Activity Clinical Trials

Recovering From Bariatric Surgery: the Effects of Early Initiated and Supervised Mobilization

Start date: February 1, 2024
Phase: N/A
Study type: Interventional

The aim is to investigate the effect of early initiated and supervised mobilization continued after discharge as management of postoperative pain and recovery following obesity surgery, including patient experiences, pain coping, physical functionality and quality of life.

NCT ID: NCT06205017 Not yet recruiting - Bariatric Surgery Clinical Trials

Post-bariatric Surgery Weaning With Food for Special Medical Purposes to Increase Patient Compliance.

AFMS_FOOD
Start date: January 9, 2024
Phase: N/A
Study type: Interventional

Due to the reduced volume and postoperative gastric edema, ingestion of solid foods in the first few days after surgery is very difficult or impossible; following bariatric surgery there are anatomical changes in the vagus that may contribute to the alteration of taste perception. In order to facilitate patient weaning and improve the liking of the foods used in this semi-liquid phase, our Center intends to test some "Foods for Special Medical Purposes" (AFMS), in order to ensure a better intake of nutrition, including in terms of vitamin D3 and calcium, good palatability and thus a better adherence to the recommended nutritional indications in the immediate postoperative period than the homogenized foods used in the standard diet.

NCT ID: NCT06192693 Not yet recruiting - Type 2 Diabetes Clinical Trials

Fecal Microbiota Transfer to Improve Diabetes Control Post-bariatric Surgery

DRIFTER
Start date: January 2024
Phase: Phase 3
Study type: Interventional

Obesity progresses worldwide with few effective treatments leading to a burst in Bariatric surgery (BS). France is the 3rd country in BS numbers yearly. BS improves diabetes (T2D) and even induces diabetes remission (DR) in 60% of patients. Thus, an expert consensus recommended extending BS to T2D with BMI≥30kg/m² with uncontrolled glycaemia, anticipating even more BS. Glycaemic control further deteriorates in the longer term in non DR (NDR) patients and relapse occurs in some DR patients, urging the need to add new therapy to control glycaemia and provide new recommendations in the future. Obesity and T2D are characterized by gut microbiota dysbiosis with low to very low microbial gene richness (MGR). About 75% of patients' candidates for BS are in the low MGR category. Whereas BS modifies microbiota composition and increases MGR 1-year post-BS, we demonstrated that only a few patients reach high MGR. Dysbiosis can be improved by several means; fibre enriched diet, prebiotics, probiotics also improve metabolic alterations and insulin resistance in mice. However, human studies observed rather divergent results: some studies display a beneficial effect in improving insulin-resistance but to a small extent while others do not display any significant effects at all. Therefore, other innovative strategies should be tested in humans. For example, Faecal microbiota transfer (FMT) ameliorates insulin sensitivity and MGR in metabolic syndrome patients, but was never tested in T2D nor post-BS. Whether adding such an innovative therapy to further modify gut microbiota post-BS can help improve glucose control should be tested. FMT showed health benefits in several diseases (clostridium difficile (CD) and Crohn's). Until recently, FMT was performed using invasive tool (endoscopy or colonoscopy) thus with potential secondary effects, or enema yet maybe less effective. Recent technologic developments enabled to generate oral capsulized FMT (filled with fecal material) performing as well as invasive FMT for CD with good tolerance. This strategy has never been tested in obesity or T2D, whereas in metabolic syndrome patients (before T2D occurrence) and less severe dysbiosis, a proof-of-concept study showed that endoscopic FMT may improve insulin sensitivity after 6 weeks. Yet these studies have included a small number of patients, non T2D and did not test oral FMT. We here hypothesize that an intervention improving dysbiosis after 1-year post-BS might help improve/maintain diabetes control in the long-term. We will examine the effects of FMT (from lean healthy donors) vs. placebo transfer in dietary-controlled non-DR patients after 1-year post-BS, on Hba1c reduction evaluated 6 months' post-intervention

NCT ID: NCT05962671 Not yet recruiting - Anesthesia Clinical Trials

Opioid-sparing Versus Sevoflurane Anesthesia on Early Postoperative Hypoventilation in Laparoscopic Bariatric Surgery

Start date: August 10, 2023
Phase: Phase 4
Study type: Interventional

Determine the incidence of early post-operative hypoventilation in post-anesthesia care unit (PACU) in patients undergoing laparoscopic bariatric surgery under opioid-sparing compared with sevoflurane-based anesthesia.

NCT ID: NCT05897398 Not yet recruiting - Obesity Clinical Trials

SEMASEARCH, Retrospective/Prospective Cohort Nested at ATUc/AP2 WEGOVY®

SEMASEARCH
Start date: April 2024
Phase:
Study type: Observational [Patient Registry]

The aim of the SEMASEARCH project is therefore to constitute a retrospective cohort, from the available data on patients already included in the ATUc/AP2, and prospective, on new patients who will initiate treatment according to the AP2 PUT, of 15 Specialized Obesity Centers in order to describe the effect of WEGOVY® treatment in this population. Thanks to a high phenotyping, subpopulations of interest will be identified to know the specifics of the effect of the treatment in these subgroups of interest. Secondary analyses will aim to look for clinical or biological biomarkers of success in the weight response to WEGOVY® in the entire prospective cohort, but also in specific subpopulations. In summary, the analysis of the entire SEMASEARCH cohort and sub-populations of interest will be based on a complete clinical phenotyping of patients (included in retrospective and prospective studies), completed by ad hoc questionnaires and associated with biological markers (prospective) partly collected within the framework of the WEGOVY® AP (glycaemia, hepatic assessment, lipid assessment ) and partly from a biobank to test specific hypotheses (predictive role of leptin sensitivity, insulin sensitivity level, plasma level of endocannabinoids, etc.). In addition, approaches using artificial intelligence (AI), notably machine learning, will make it possible to determine the variables or combination of variables that are most predictive of the weight response to treatment with WEGOVY® in the largest population. Indeed, individual weight loss in response to weight loss strategies is highly variable, whether purely related to lifestyle changes or pharmacological. Well-known factors associated with the ability to lose weight include adherence to lifestyle change, gender, age and specific medications. However, after controlling for these factors, differences in weight loss appear to persist in response to different interventions including pharmacological ones. Adaptation to energy deficit involves complex feedback mechanisms, and inter-individual differences are likely to arise from a range of poorly defined factors. Thus, a better understanding of the factors involved in inter-individual variability in response to WEGOVY® will help guide more personalised approaches to the management of these patients. AI techniques will be used to determine which combination of clinical or biological variables are most predictive of weight response.

NCT ID: NCT05720351 Not yet recruiting - Bariatric Surgery Clinical Trials

Alveolar Recruitment Maneuvers on Reduction of Lung Atelectasis in Bariatric Surgery by Using Lung Ultrasound Score

Start date: August 10, 2023
Phase: N/A
Study type: Interventional

The study aims to compare the staircase alveolar recruitment maneuver with PEEP titration versus sustained inflation alveolar recruitment maneuver by using lung ultrasound score as an indicator of improving lung atelectasis in bariatric surgery

NCT ID: NCT05386979 Not yet recruiting - Bariatric Surgery Clinical Trials

Multimodal Analgesic Management of Naborphine Combined With Opioid Free Anesthesia in OSA Patients Undergoing Bariatric Surgery

Start date: May 15, 2022
Phase: N/A
Study type: Interventional

Comparative study to explore the effect of opioid free anesthesia technology in perioperative analgesia management, clarify the effect of naborphine instead of opioids on perioperative analgesia management in morbid obesity patients with moderate and severe OSA, reduce related adverse events, and explore the latest clinical anesthetic drugs.

NCT ID: NCT05240443 Not yet recruiting - Obesity Clinical Trials

Bariatric Surgery and Chronic Renal Disease

BARICADE
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

Obesity can be a major driver for the development of chronic kidney disease (CKD), which is a leading cause of death and significant loss in quality of life. A growing body of evidence has shown bariatric (metabolic) surgery as a novel approach to reduce the progression of CKD and reduce morbidity with sustained weight loss. This pilot trial will inform the design and execution of a large RCT that could determine the efficacy of bariatric surgery in the treatment of patients with CKD in the context of obesity. Ultimately, the results have the potential to influence guidelines that may deem bariatric surgery as a viable treatment option for CKD and reduce the morbidity from this chronic condition and inform clinical practice.