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100 active trials for Obesity Morbid

Deep Transcranial Magnetic Stimulation (dTMS) of the Medial Prefrontal Cortex in Food Addiction and Obesity

This experiment is based on a unique technique of deep Transcranial magnetic stimulation (dTMS) of the brain's cortex, aiming to produce weight loss in food-addicted severely obese adults.

Start: January 2021

Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery

The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity. Obesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation, failed intubation, pulmonary aspiration and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient. The aim of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND.

Start: December 2020

Efficacy of CPPLAI in Laparoscopic Sleeve Gastrectomy Patients

The high demand for bariatric surgery due to the increasing prevalence of obesity worldwide necessitate evidence-based clinical pathway such as Enhanced Recovery After Bariatric Surgery (ERABS). The paradigm of surgery has been shifted from open to laparoscopic in morbidly obese patients. Laparoscopic Sleeve Gastrectomy (LSG) is the most common procedure performed in our institute for sustained weight loss and amelioration of obesity-related comorbidities. Pain control in ERABS is one of the key factors for improved outcomes. Surgery induced acute postoperative pain, stress response and fatigue lead to prolonged convalescence and hospital stay. Optimal titrated safe postoperative pain management in LSG patients still remains a challenge.

Start: December 2020

The Effects of Non-surgical Periodontal Therapy in Patients Indicated for Bariatric Surgery

By World Health Organization (WHO) definition overweight (body mass index (BMI) >24.9) and obesity (BMI >29.9) are defined as abnormal or excessive fat accumulation with many possible impacts on individual's health. Association between obesity and associated metabolic syndrome (obesity, hypertension, diabetes mellitus type 2 and dyslipidemia) and oral health has become clear from several studies that proved increased odds of obese patients for developing of caries-related pathologies and periodontal disease. Periodontal disease, a major cause of tooth loss in adults, is an inflammatory disease of periodontal tissue that is initiated by dental plaque bacteria and is modulated by the inflammatory-immune host response factors. Relation between periodontal disease and obesity is bi-directional, through sharing of several proposed local and systemic pathogenesis mechanisms. For treatment of obesity, bariatric surgery (BS) procedures are methods of choice, when other less invasive options fail. They are safe, cost-effective, improve overall health and increase life expectancy. There are several types of BS interventions and most commonly performed BS is laparoscopic sleeve gastrectomy and with second most often, Roux-en-Y gastric bypass. Studies on influence of BS on periodontal health showed diverse results, with some showing no effect, while others demonstrated an increase in the prevalence of periodontitis as well as a further deterioration of periodontal tissues after BS procedure. However, studies on the prevalence of gingivitis, a reversible plaque-induced inflammation of gingiva, and its progression to periodontitis in BS patients is lacking. Furthermore, dental and periodontal status are not routinely evaluated in patients before or after BS. To the best of our knowledge studies on the effect of periodontal therapy before BS are lacking.

Start: June 2020

Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity

This is a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with severe obesity. We will also collect data that possibly could give a better understanding of mechanisms of this correlation.

Start: May 2019

Long-term, Substantial Weight Loss and Insulin Regulation of Lipolysis

It is not known how much improvement in insulin regulated lipolysis (the breakdown of triglycerides) occurs following substantial, sustained weight loss. Researchers will test the effects of inflammation and lipolysis regulation in people before and after bariatric surgery (sleeve gastrectomy) to answer these questions.

Start: August 2019

Obesity Surgery During 2020 Italian Pandemic

The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.

Start: July 2020

Functional Changes in the Stomach and Esophagus After One Anastomosis Gastric Bypass- OAGB

Evaluation of the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass (OAGB)

Start: June 2020

Contributing Factors in the Pathobiology of Airway Remodeling in Obesity

There are two aims for this study. The purpose of this study is to determine the effects of body weight and hormones on airway fibrosis (scarring) and lung function in obese & lean asthma subjects compared to obese & lean non-asthma subjects (Aim 1). And in obese subjects with asthma undergoing bariatric surgery compared to obese non-asthma subjects undergoing bariatric surgery (Aim 2).

Start: April 2018

Comparative Analysis Between Sleeve Gastrectomy and Roux-en Y Gastric Bypass in Bariatric Operation

Prospective, double-arm, multi-center cohort study on obese patients, for laparoscopic sleeve gastrectomy versus Roux-en Y gastric bypass

Start: September 2020

Aspiration Therapy for Obese Adolescents

Interventional studies devoted to adolescents are relatively rare in the world. This has several reasons. Treatment and research on obesity are centered on advanced forms of obesity in adults, bearing in mind that social and health problems make these patients cope with their condition. Studies on children tend to focus on epidemiology. On the other hand, effective long-term effective treatment is not just for young adults and adolescents. However, appropriate long-term weight reduction methods could help with chronic obesity at the onset of the disease. Here, the ideal scheme at the outset of the disease is to use less invasive endoscopic methods and then use invasive surgical methods at a later age. The benefit of this study will certainly be to find out the reality of the use of this endoscopic method in young obese individuals, that is, population groups where, according to the WHO and CDC (Centers for Disease Control and Prevention), there has been a rapid increase in the incidence of obesity especially during the last 20 years.

Start: August 2018

Brown Adipose Tissue Activation by Spinal Cord Stimulation

The objective of this study is to investigate and utilize spinal cord stimulation (SCS) as an effective approach to eliciting weight loss and potentially alleviating Type 2 diabetes mellitus (DM), as evidenced by increasing metabolism of adipose tissue.

Start: September 2020

ED90 for Hyperbaric Bupivacaine in Super Obese Parturients

The aim of this study is to determine the ED90 of hyperbaric intrathecal bupivacaine for the super obese population undergoing cesarean section under a combined spinal epidural technique.

Start: May 2019

Effectiveness of Dapagliflozin for Weight Loss

Mexico has one of the highest prevalence of obesity, reported on 32.4 percent of people over 20 years old, with a prevalence of obesity class III of 1.8 percent on males and 4.1 percent on females. According to previous data in our Obesity Clinic the mean age of these patients is 41 years, 46 percent have pre-diabetes or type 2 diabetes mellitus (T2D); 66 percent has hypertension and 33 percent has dyslipidemia. The management of alterations in the glucose metabolism in this unit is made by dietary treatment and with the use of metformin at doses of 1,700 mg/day and/or basal insulin. Dapagliflozin is a selective SGLT2 inhibitor than has shown a sustained effect on the reduction of glycated hemoglobin at 0.4 to 0.8 percent (initial 7.8 to 8.0 percent). Additionally, due to the induction of glycosuria up to 20 to 85 g/day, it has been calculated that its use induces a caloric deficit at 80 to 340 kcal/day. This has been tested in patients with T2D in which induces a weight loss of 2 to 3 kg and in combination with metformin even a weight loss up to 5.07 kg (-6.21 to 3.93 kg) without regain (at least for 2 years). Furthermore, dapagliflozin decrease systolic blood pressure, increases HDL cholesterol concentrations and decreases triglyceride concentration. The drug product action is independent of the insulin production at pancreas, consequently, it exists a possibility of using the drug product on patients with prediabetes or even on other types of diabetes. Regarding the adverse effects related to its use, it has been described an increase in the risk of genitourinary infections with a low risk for inducing hypoglycemia. A previous study that included 182 patients with T2D inadequately controlled with metformin assessed the effect of dapagliflozin 10 mg in total weight loss after 24 weeks compared to placebo. It was found a decrease in weight of 2.08 kg (2.8 to 1.31 kg), decrease in waist circumference of 1.52 cm (2.74 to 0.31), decrease in total fat mass assessed with densitometry of 1.48 kg (2.22 to 0.74), decrease of visceral fat mass of 258.4 cm^3 (448.1 to 68.6) and subcutaneous fat of 184.9 cm^3 (359.7 to 10.1). Most of these studies on weight and metabolic control have been performed in patients with obesity class II or I. The aim of this study is to assess if dapagliflozin in combination with metformin is at least 10 percent more effective for weight reduction in comparison with metformin in patients with prediabetes or T2D and obesity grade III.

Start: July 2018

Quality of Life After Bariatric Surgery

This study aims to assess long term outcomes for patients who have underwent bariatric surgery. In particular, it aims to assess the quality of life of these participants.

Start: June 2020

Reducing Sedentary Time in Bariatric: The Take a STAND for Health Study

This research program aims to comprehensively investigate the clinical, physiological, metabolic, and molecular effects of reducing sedentary behavior in post-bariatric patients. To this aim, we will conduct a crossover trial and a randomized controlled trial. The crossover trial aims to unravel potential mechanisms underlying the metabolic, physiological and molecular effects of breaking up sedentary time with light-intensity physical activity versus carrying out the minimum amount of daily exercise at once and then remaining sedentary versus simply remaining sedentary throughout all sessions, in a well-controlled laboratorial condition. The 4-month parallel-group randomized controlled trials aim to investigate the feasibility and efficacy of a newly developed personalized intervention focused on replacing sedentary time with light- (or very light-) intensity physical activity in these patients. A multitude of gold-standard techniques will be applied to evaluate the effects of the intervention on several outcomes, including sedentary time (primary outcome), physical activity levels, clinical parameters specific to each condition, cardiometabolic risk factors, immune function, and health-related quality of life.

Start: September 2020

Different Limb Lengths in Gastric Bypass Surgery

Obesity and type 2 diabetes mellitus (T2DM) are reaching epidemic proportions in the developed world. In morbidly obese patients only surgical treatment (bariatric operations) leads to a sustained weight loss and relief of co-morbidities in the majority of patients. One of the most frequently performed operations is the laparoscopic proximal Roux-en-Y gastric bypass (LRYGB). There is still lack of knowledge why some patients respond much better than others to an identically performed procedure. Therefore, a number of variations of this operation have been introduced over the past 50 years. Increasing the length of small bowel being bypassed has the potential to improve the effect of the operation but buries the risk of nutrient deficiencies. The metabolic effect of LRYGB occurs, in part, independently of weight loss. The mechanisms underlying metabolic improvement through metabolic surgery are not yet fully understood.

Start: June 2020

Non-randomized Prospective Comparison Between SASI Bipartition and RYGB

The main aim of this project is to assess the safety and efficiency of the SASI Bipartition.

Start: August 2020

Preoperative Carbohydrate Loading in Bariatric Surgery

The aim of this study is to perform a randomized non-blinded clinical trial to assess influence of preoperative carbohydrates loading in patients undergoing bariatric surgery measured by changes in the course of the postoperative period, changes in body composition and changes in insulin resistance

Start: July 2020

Traxi Panniculus Retractor for Cesarean Delivery

This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.

Start: October 2018