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Bariatric Surgery clinical trials

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NCT ID: NCT04746703 Recruiting - Bariatric Surgery Clinical Trials

New Imaging Tools to Explore Impact of Bariatric Surgery on Pancreatic Lesions: PACHIBA- Bariatric Surg

PACHIBA
Start date: February 10, 2021
Phase: N/A
Study type: Interventional

The investigators propose an exploratory study aiming at assessing the impact of surgical bariatric treatment on the improvement of pancreatic lesions detected by MRI. Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery. To assess the impact of bariatric surgery on pancreatic Magnetic Resonance Imaging (MRI) parameters in severe-obese patients

NCT ID: NCT04742010 Recruiting - Bariatric Surgery Clinical Trials

Zoledronic Acid for Prevention of Bone Loss After BAriatric Surgery (ZABAS)

ZABAS
Start date: February 20, 2021
Phase: Phase 2
Study type: Interventional

In a randomised placebo-controlled trial assess effects of zoledronic acid for prevention of bone and muscle loss after bariatric surgery.

NCT ID: NCT04651361 Recruiting - Obesity Clinical Trials

Naldebain for Pain Control After Bariatric Surgery

Start date: June 24, 2021
Phase: Phase 2/Phase 3
Study type: Interventional

Laparoscopic gastric sleeve and bypass surgeries the most common bariatric procedures for weight loss and improved management of metabolic syndromes. Patients may suffer from wound pain or referred pain after laparoscopic bariatric operation. Most importantly, 11.8% of these patients complained surgical-related pain one year after operation, and 8% of them required prolonged use of opioid to control chronic postoperative pain (CPSP). However, there are currently lack of clinical practice guidelines or recommendations for prevention of CPSP after laparoscopic abdominal surgery. Although regional block techniques (i.e. truncal block or intrathecal opioid) are considered as effective supplementary analgesic approaches to improve postoperative pain control, parenteral administration of analgesics remain as the mainstay for pain management of laparoscopic abdominal surgery. Naldebain® is prodrug of nalbuphine, which was approved by the Taiwan FDA in 2017. Naldebain® is an extended-release dinalbuphine sebacate, and is rapidly hydrolyzed by tissue of plasma esterase to release nalbuphine. A number of clinical studies have shown that single-dose of pre-operative intramuscular administration of Naldebain® provides significantly higher analgesic effect up to 1 week in hemorrhoidectomy and laparotomy surgery with a well-tolerated safety profile. Therefore, this PI-initiated randomized, double-blind, placebo-control trial aims to investigate the clinical efficacy of Naldebain® in management of acute postoperative pain in patients receiving laparoscopic gastric sleeve or bypass surgery, and prevention of the development of CPSP after surgery. This study will also analyze the plasma levels of nalbuphine following a single intramuscular injection in obese patients.

NCT ID: NCT04639778 Recruiting - Bariatric Surgery Clinical Trials

Monitoring the Weight Evolution Using a Connected Scale

TELEBARIA
Start date: March 25, 2021
Phase: N/A
Study type: Interventional

Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation. This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.

NCT ID: NCT04634929 Recruiting - Obesity Clinical Trials

Endocrinological and Neuronal Aspects of Bariatric Surgery

BACEN
Start date: December 1, 2020
Phase:
Study type: Observational

The overall aim of the proposed project is to investigate the contribution of changes in neuronal food processing, hypothalamic reactivity and hormonal factors to weight loss after bariatric surgery.

NCT ID: NCT04614961 Recruiting - Clinical trials for Overweight and Obesity

Database Concerning Patients Consulting the Obesity Clinic

Start date: November 12, 2019
Phase:
Study type: Observational [Patient Registry]

A registry of individuals that visit the Obesity Clinic of the University Hospitals of Leuven will be established. The objective of this registry is to improve the knowledge about obesity, the treatment of obesity and its outcomes.

NCT ID: NCT04583150 Recruiting - Obesity Clinical Trials

Ovarian Reserve and Bariatric Surgery

BARIAOVO
Start date: December 3, 2020
Phase:
Study type: Observational

The expansion of the obesity epidemic is accompanied with an increase in bariatric procedures, in particular in women of reproductive age. Severe obesity has negative effects on fertility and on in vitro fertilization (IVF) outcomes, and the weight loss induced by the bariatric surgery (BS) is believed to reverse the deleterious impact of overweight and obesity on female fertility. However, research is limited to retrospective cohort studies, small case-series and case-control studies. Weight reduction has been shown to improve fecundity and hormonal state of a subgroup of obese patients with polycystic ovary syndrome (PCOS). In this population, recent studies have demonstrated an increase of naturally conceived pregnancies following bariatric surgery. However, these studies have evaluated only short-term evolution of ovarian function and not all studies demonstrated improvements in fertility outcomes after BS. Clearly, more studies are needed regarding the effect of BS on obesity-related infertility, and long-term outcome of ovarian function has to be assessed. Markers of ovarian reserve, including Follicle Stimulating Hormone (FSH), antral follicle count (AFC), and anti-mullerian hormone (AMH), have been used to counsel patients regarding in their reproductive outcomes. Serum AMH concentrations remain remarkably stable throughout the menstrual cycle, which is a great advantage over other markers of fertility. Various studies have evaluated the association between AMH and body mass index (BMI) but reported contradictory results. Some of them have reported a significant inverse correlation between AMH and BMI, but others found no relationship between AMH and BMI. Scarce and small preliminary studies have been performed to evaluate AMH changes after surgical weight loss and showed a decrease in serum AMH.

NCT ID: NCT04581447 Recruiting - Diabetes Clinical Trials

Extending Time Without Diabetes After Bariatric Surgery: a Trial Comparing the Metformin Addition or Not to Standard Care

DiabOUT
Start date: January 7, 2021
Phase: Phase 3
Study type: Interventional

This study is a randomized trial that evaluates the effect of metformin addition or not to standard care on the duration of diabetes remission after bariatric surgery.

NCT ID: NCT04501042 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Investigation on the Role of Gut-liver Axis for Non-alcoholic Steatohepatitis Through Bariatric Surgery

Start date: May 16, 2019
Phase:
Study type: Observational

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease. Non-alcoholic steatohepatitis (NASH) is an aggressive form of NAFLD with remarkable inflammatory features which may cause advanced fibrosis and liver cancer. So far there is no FDA-approved drug for treating NASH. A 10% weight loss by life style modification is a standard recommendation to treat NASH which achieves only 10-20% success rate in clinical practice. Thus, the development of therapeutics to prevent and treat NASH is certainly an unmet need. For now, the mechanism of how simple steatosis progresses to NASH remains unclear and accumulating evidences suggest the role of gut microbiota may be essential. Studies have also noted the bariatric surgery effectively improve diabetes and NASH with significant alterations in the composition and function of gut microbiome. In this study, the investigators aim to investigate the role of gut microbiota in the pathophysiology of NASH by comparing NAFLD severity, gut microbiome, metabolomics, immune profiles among patients before and after the bariatric surgery. With these efforts, the investigators wish to decipher the mechanism of how bariatric surgery may improve NASH through changing the gut microbiota and find out microbe-associated molecular signatures between NASH and NAFLD through this study.

NCT ID: NCT04486417 Recruiting - Obesity Clinical Trials

Feasibility of a Telematics Pre-operative Assessment in a Bariatric Surgery During Covid-19

Start date: June 1, 2020
Phase:
Study type: Observational

Coronavirus (COVID-19) is a respiratory disease caused by a newly discovered coronavirus, SARS-CoV-2. Several recent papers on the pandemic recognized obesity as a risk factor for the COVID-19 infection. Therefore, an effective treatment for obesity even during COVID-19 outbreak is needed. Bariatric surgery, is considered an effective treatment in the reduction of obesity-related comorbidities and mortality risk. However, during Covid-19 phase 1 (lockdown) the near totality of elective non-oncologic procedures, including bariatric surgery, has been postponed, and all the outpatients' visits too. Therefore, phase 1 led to completely change the way of managing the pre-operative multidisciplinary visits considering the hospital limitation access and the restriction. In the present study the investigators explored the use of telemedicine as a possible strategy to face this new situation. Specifically, this study aims to test the efficacy of an online structured protocol based on pre-operative multidisciplinary assessment using telemedicine instruments. In particular, the primary end point is to test the feasibility of a telematics pre-operative work-up. The secondary end points are evaluating patient's compliance and satisfaction to the online assessment.