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57 active trials for Morbid Obesity

Ketamine Infusion vs Dexmedetomidine Infusion in Obese Patients Undergoing Bariatric Surgery

The surgeries that involve treatment of morbid obesity, i.e. bypass procedure and sleeve gastrectomy, are collectively covered under the term 'bariatric surgery'. The frequency of bariatric surgery has been increasing worldwide for patients with medically complicated obesity who have difficulty losing weight by other methods The growth of bariatric surgery is accompanied with development of anesthetic techniques to maintain patient safety and improve outcome. Treatment with narcotics in obese patients has dual effect. Increased use of narcotics are associated with multiple complications including Postoperative Nausea and Vomiting (PONV) , respiratory depression and elevated risk of Obstructive Sleep Apnea (OSA) complications . On the other hand, the reduction in opioid use may result in acute post-operative pain that may limit post-surgery rehabilitation. Therefore, we need to minimize opioid use and employ some other drugs which, besides having analgesia, has an opioid-sparing effect also. Ketamine, an N-methyl-D-aspartate (NMDA) receptor antagonist, has analgesic properties in sub-anesthetic doses. When used in low dose (0.3 to 0.5 mg/kg) by ideal body weight, it is an analgesic, anti-hyperalgesic, and prevents development of opioid tolerance. Dexmedetomidine is selective ?2-Adrenoceptor agonist that has been used as an adjuvant to anesthetic agents in perioperative period for several adventitious profile as well as tolerated side effects . While dexmedetomidine is emerging as a beneficial adjunct to the analgesic regimen in the perioperative period, its utilization is not routinely widespread .

Start: April 2021
Comparison of Three Hypoabsortive Surgical Techniques for Treatment of Type IV Morbid Obesity

Morbid obesity is the first non-traumatic cause of death in the western population and it is also progressively beginning to affect the developing countries. Bariatric surgery provides better results than pharmacological treatments and lifestyle changes, granting a better control of comorbidities. Duodenal switch (DS) has proben to be the most effective surgical treatment for grade IV morbid obesity and its comorbidities. However, it is not widely used due to its technical complexity and the risk of long-term complications. Single Anastomosis Duodenum-Ileal bypass with Sleeve gastrectomy (SADI-S) was concieved in 2007 as a one-anastomosis simplification of DS, intended to diminish the surgical time and postoperative risks. Recently, another simplified hypo-absorptive technique has started to be widely used: the one anastomosis gastric bypass (OAGBP), also called mini-gastric gypass. It consists of a gastric pouch associated with a gastro-jejunal anastomosis in omega (Billroth II). Despite the potential advantages of these emerging surgical techniques (SADI-S and OAGBP), there is no solid evidence on its efficacy for the treatment of grade IV obesity in comparison with DS. Besides, there is also there is a lack of studies reporting on prospective acid and bile reflux after omega digestive reconstructions, suche as "Billroth II-like" (SADI-S) and "Billroth II" (OAGBP). Bile reflux is potentially premalignant condition. This prospective randomized study aims to compare conventional DS with SADI-S and OAGBP. We include all morbidly obese patients with BMI ? 50 kg/m2 aged 18 years or more. Exclusion criteria are patients who do not fulfill our preoperative bariatric assessment for surgery and those with contraindications for hypo absorptive or mixed surgery. The main objective of the study is to compare the percentage of excess weight lost at 2 and 5 years after the three different surgical procedures. As a secondary objective, gastroesophageal reflux (GERD) will be compared before and 2 years after surgery, based on GERD symptoms test, gastroscopy and a esophageal pH-impedanciometry in selected patients. Other secondary objectives are comparison of short-term complications, metabolic comorbidities, depositional habit, quality of life and metabolic and nutritional deficiencies at two years of surgery.

Start: April 2021
Establishment of the Human Intestinal and Salivary Microbiota Biobank - Obesity

This is a prospective, clinical, multicentre study aimed to collect biological samples and study microbiota from subjects with morbid obesity, metabolically healthy obesity and from healthy volunteers. Microbiota is a complex consortium of microorganisms, located at the mucosal level (in particular intestinal, oral and vaginal) having a key role in human health and in the onset of several diseases. Microbiota alterations have been found in several diseases (gastrointestinal, metabolic, renal, oncological, gynaecological) The study will allow to: Provide biological samples (faeces, saliva, blood, urine) from healthy volunteers and patients to the first Italian microbiota biobank; Study microorganisms using different in vitro and in vivo techniques; Study the link between the microbiota and the disease. This study is part of the BIOMIS project (Project Code: ARS01_01220), presented as part of the "Avviso per la presentazione di progetti di ricerca industriale e sviluppo sperimentale nelle 12 aree di specializzazione individuate dal PNR 2015-2020" and admitted to funding under the National Operational Program "Ricerca e Innovazione" 2014-2020 by directorial decree of MIUR - Department for Higher Education and Research - n. 2298 of 12 September 2018. BIOMIS includes several clinical studies that enrol patients with different pathologies to collect and store biological samples and study microbiota.

Start: March 2021
Bariatric Embolization of Arteries With Imaging Visible Embolics (BEATLES)

Obesity is defined as a body mass index (BMI) ?30 kg/m2 and with a subclass of obesity known as morbid or severe obesity (BMI of ?40 kg/m2). These are major issues in medicine for both participants and medical providers with >36% of the US population affected. Obesity is one of the biggest causes of preventable chronic diseases and healthcare costs in the USA. Obese adults spend 42% more on direct healthcare costs and morbidly obese adults overall have 81% higher healthcare costs than non-obese adults. Obesity is currently treated with dietary, pharmacological, and/or surgical approaches that are often unsuccessful or are associated with additional risks. As the incidence and prevalence of obesity and obesity-related diseases are steadily increasing, there is a growing need to detect the key risk factors involved in disease development and modify standard treatment procedures and protocols. The most successful long-term strategy continues to be bariatric and metabolic surgeries, such as sleeve gastrectomy and Roux-en-Y gastric bypass (RYGBP). The NIH recommends bariatric surgery for participants with a BMI of 40 kg/m2 or greater or a BMI of 35 kg/m2 or greater and obesity related comorbidities. These surgeries enable participants to lose between 50% and 75% of excess body weight. Despite this success, participants are apprehensive and do not undergo bariatric surgery with the biggest fear being the many complications that come with the procedure. Studies have shown that 57-77% of participants are not interested in bariatric surgery although the participants qualify.(16) With the concern of complications from bariatric surgery, interest in endoscopic bariatric techniques has increased over the years. The techniques have been shown to be efficacious, reversible, relatively safe, and cost effective. Further, these techniques offer a therapeutic window for some participants who may otherwise be unable to undergo bariatric surgery. The American Society for Gastrointestinal Endoscopy have approved endoscopic procedures, such as balloon therapy, for participants with BMI in the 30-40 kg/m2 range.(17,18) However, the products used in these therapies also have several limitations primarily the inability to provide long term weight loss given the temporary nature of these balloons.(19) Common adverse events following intragastric balloon insertion include abdominal pain (33.7%), gastroesophageal reflux disease (18.3%), anorexia, and nausea (29%). Severe complications such as gastric ulcers (2%), small bowel obstruction (0.3%), perforation (0.1%), balloon migration (1.4%), and death (0.08%) are less common. Early balloon removal occurred in 9.1% of the study participants due to participant intolerance.(20) In a pilot study to assess safety and efficacy (BEAT Obesity), 20 morbidly obese participants with a BMI of ?40 kg/m2 with no other comorbid conditions underwent bariatric embolization and were followed for 12 months. Participants were embolized with 300-500 µm Embospheres. None of the 20 participants in the BEAT Obesity trial (the largest prospective trial to date) had any major adverse events. Any gastric ulcers that occurred (40%) were asymptomatic and were completely healed by three months after the procedure.(21) There were many limitations of this study including the absence of a control cohort and non-compliance amongst study participants. A target population of participants with a BMI of 40 kg/m2 and above was too high considering the bariatric embolization procedure is comparable to endoscopic bariatric therapies rather than bariatric surgery. BEAT Obesity excluded participants with comorbidities, such as those who suffer from diabetes, who may greatly benefit from this procedure and are often the target population for endoscopic/surgical bariatric therapies. A larger bead size of 300-500 µm was specifically chosen compared to preclinical data and prior clinical reports due to concerns of gastric ischemia and ulceration. However, smaller bead size produces greater weight loss and hormonal shifts.(22) Investigators hypothesize that transvascular bariatric embolization results in safe and effective weight loss in obese participants compared to control subjects.

Start: January 2020