Clinical Research Directory

Glycemic Variability After SASI Versus Roux-en-Y Gastric Bypass

The GLUBARI trial is a prospective, randomized, single-center clinical study comparing two bariatric surgical procedures in adults with morbid obesity: Single Anastomosis Sleeve Ileal Bypass (SASI) and Roux-en-Y Gastric Bypass (RYGB). The main objective is to compare glycemic variability between the two procedures using continuous glucose monitoring. Participants will undergo continuous glucose monitoring for 7 days before surgery and again at 6 and 12 months after surgery. Secondary outcomes include hypoglycemic events, weight loss, resolution of obesity-related comorbidities, postoperative complications, gastroesophageal reflux, nutritional deficiencies, and quality of life. A total of 68 participants will be randomized in a 1:1 ratio to SASI or RYGB and followed for 12 months after surgery.

Structured Perioperative Nursing Education and Short-Term Outcomes After Metabolic Bariatric Surgery

This study evaluated whether a structured, nurse-led perioperative education program, supported by an illustrated Arabic booklet, is associated with better short-term outcomes in adults undergoing metabolic and bariatric surgery (MBS). The main outcome was eating behavior at 6 months after surgery. Other outcomes were knowledge about bariatric surgery, weight loss, quality of life, and recorded postoperative symptoms and events. Patients who received routine hospital care were compared with patients who received the structured education program.

Identification of Pre-surgical Phenotypic Indicators Predictive of Quality of Life Trajectories in Obese Patients Following Bariatric Surgery

This study aims to identify pre-operative phenotypic determinants predictive of quality of life trajectories in post-bariatric surgery patients. In addition, this study will have as a secondary objective the highlighting of a potential link between post-surgery quality of life trajectories and those of anxiety/depression scores, eating behaviors and body mass indices. This study will be conducted during the usual care of patients undergoing the GEROM73 program, lasting a total of 30 months. The GEROM73 program includes care for the six months preceding bariatric surgery and the 24 months following surgery. This program supports patients throughout their bariatric care.. Throughout the GEROM73 program, patients will complete questionnaires on anxiety, depression, eating disorders, Impact of Weight on Quality Of Life. Patients' weight, body mass index and body schema will also be measured throughout the GEROM program.

Multimodal Analgesia Effect on Post Surgical Patient

Patients undergoing Bariatric Surgery at the University of California Davis Medical Center will be divided into two groups, one receiving Standard of Care pain control medications vs the second group which will receive non-narcotic pain medications with rescue pain medications available if needed

Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach

Variable outcomes after weight loss surgery are likely attributable to complex, poorly understood mechanisms. Due to the significant impact that morbid obesity has on a patient's health, successful management of obesity and its related comorbid medical conditions is important and thus necessitates continued improved therapies for treating obesity. Although the mechanisms of weight loss after surgical intervention are poorly understood, improved understanding of molecular and metabolic changes that occur after weight loss surgery may offer the ability to provide targeted precision therapy for patients with morbid obesity undergoing surgical therapy. In this proposal, the investigators will combine a clinical trial whereby modifications to the gold-standard for weight loss surgery, the gastric bypass, are evaluated while simultaneously measuring molecular and metabolic changes that occur in response to these weight loss procedures. Through creating variable lengths of bypass intestine after gastric bypass, the investigators will be able to determine the effect of malabsorption on clinical outcomes and mechanisms involved in weight loss after gastric bypass. The investigators will also use two control groups. One will be a surgical weight loss control group and consist of patients undergoing a laparoscopic sleeve gastrectomy, a non-intestinal bypass procedure. The other group will consist of patients having non-surgical weight loss therapy. To asses metabolic changes that occur in response to surgical weight therapy and specifically intestinal bypass and malabsorption, the investigators will examine changes in the gut microbiome and plasma gut enteroendocrine hormones. To evaluate molecular pathways that are impacted as a result of gastric bypass and malabsorption, the investigators will measure circulating microRNAs (miRNAs) in the blood. Measurement of miRNAs will provide data on an easily measurable molecular marker for each treatment group. This is a first step in translational exploration of mechanisms of weight loss after surgery by evaluating both clinical and molecular/metabolic outcomes and begin an explorative process towards creating an individualized approach to improving outcomes after weight loss surgery.

The UFO (Ultra Processed Foods in Obesity) Project

The childhood obesity prevalence has increased dramatically in the last decades, affecting more than 340 million children worldwide. This condition is the major risk factor for a set of metabolic abnormalities, also known as metabolic syndrome, a condition that reduce life expectancy by 5-20 years. Changes in the global food system, and the increased consumption of ultra-processed foods (UPFs), may have contributed to the increase in the prevalence of childhood obesity and related morbidities. The mechanisms by which UPFs might promote obesity and metabolic syndrome could be multiple and not completely identified. The Ultra-processed Food in Obesity (UFO) Project has been designed to investigate the potential associations between UPFs intake and MetS in pediatric subjects

Postoperative Nausea, Vomiting and Pain After Bariatric Surgery - a National Registry Study

Around 4,000-5,000 bariatric (weight-loss) operations are performed in Sweden every year. Nausea, vomiting and pain are common immediately after these operations, cause considerable suffering and increase the intensity and length of hospital care. Bariatric surgery is one of the procedures with the highest risk of postoperative nausea and vomiting (PONV): about one third of patients experience PONV already in the recovery unit, and registry data indicate that around 40% report severe pain at the same stage. This study links two national quality registries - the Swedish Perioperative Register (SPOR) and the Scandinavian Obesity Surgery Registry (SOReg) - to describe how often adult patients experience nausea, vomiting and pain in the post-anaesthesia care unit after primary bariatric surgery, and to identify patient, anaesthetic and surgical factors associated with these outcomes. The study tests whether total intravenous anaesthesia, the addition of a regional nerve block, and preoperative health-related quality of life are associated with PONV and pain, and whether early PONV or pain is associated with complications, unplanned hospital care or reoperation up to one year after surgery. The results are intended to show how well current evidence on preventing PONV and pain is applied in everyday practice and where care can be improved.

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.

Bariatric Surgery and Pharmacokinetics of Paracetamol

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on paracetamol are investigated.

Bariatric Surgery and Pharmacokinetics of Metoprolol

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on metoprolol are investigated.

Bariatric Surgery and Pharmacokinetics of Losartan

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on losartan are investigated.

Bariatric Surgery and Pharmacokinetics of Lamotrigine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lamotrigine are investigated.

Bariatric Surgery and Pharmacokinetics of Valsartan

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on valsartan are investigated.

Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients

Around 20% of the obese patients with higher body mass index (BMI) who are taken off the breathing tube and breathing machine (ventilator) end up needing it back to support breathing. The re-application of breathing tube is associated with poor outcomes, including high risk of pneumonia, longer hospital stays, and death. The purpose of this study is to assess if prophylactic use of noninvasive breathing support after removing the breathing tube lowers the chance of needing the breathing tube again.

Impact of MBS on Body Composition, Basal Metabolic Rates and Muscle Functions in Morbid Obese Patients

PRIMARY OBJECTIVE To evaluate the changes in body composition in morbid obese patients following bariatric and metabolic surgery Secondary Objectives: 1. To assess changes in BMR in obese patients following bariatric surgery 2. To evaluate muscles strength and muscle performance parameters in obese patients following bariatric surgery 3. To assess change in inflammatory and metabolic parameters following bariatric surgery In this study, morbidly obese patients undergoing bariatric surgery will be assessed at baseline and followed by 3rd and 6 months to evaluate various physiological and biochemical changes. Anthropometric measurements including height, weight, BMI, and waist-hip ratio will be recorded. Body composition will be assessed using Bioelectrical Impedance Analysis (BIA), which will provide data on percentage body fat (PBF), segmental muscle mass (SMM), segmental fat mass (SFM), and skeletal muscle index (SMI). Basal metabolic rate (BMR) will also be measured through BIA. Muscle strength will be evaluated using a hand grip dynamometer, while muscle performance will be assessed via gait speed using the 6-meter walk test. Inflammatory markers such as high-sensitivity C-reactive protein (HsCRP), erythrocyte sedimentation rate (ESR), and interleukin-6 (IL-6) will be analyzed. Additionally, metabolic parameters including thyroid-stimulating hormone (TSH), fasting and postprandial blood glucose, HbA1c, and lipid profile will be measured to understand the systemic effects of the surgery.

Responsive Neurostimulation For Loss Of Control Eating

The primary objective of this trial is to assess device function and safety, with secondary objectives including the feasibility.

Flow-Controlled vs Volume-Controlled Ventilation in Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery

The goal of this clinical trial is to compare the effects of flow-controlled ventilation (FCV) and volume-controlled ventilation (VCV) on hemodynamic and respiratory parameters in obese patients undergoing elective laparoscopic bariatric surgery. The main questions it aims to answer are: Does FCV provide better intraoperative hemodynamic and respiratory stability compared to VCV during laparoscopic bariatric surgery? Is FCV a safe and feasible ventilation strategy under high intraabdominal pressure and position changes required in bariatric surgery? Researchers will compare FCV group to VCV group to see if FCV improves intraoperative respiratory mechanics and hemodynamic parameters. Participants will: Undergo elective laparoscopic bariatric surgery with BMI \>40 kg/m² (ASA I-III) Receive either flow-controlled or volume-controlled ventilation with individualized PEEP and tidal volume of 6-8 ml/kg predicted body weight Have intraoperative hemodynamic and respiratory parameters monitored at regular intervals, including arterial blood gas analysis Be followed postoperatively for oxygen therapy requirement and intensive care need

Investigating Metabolic, Brain, and Cognitive Alterations Through Bariatric Surgery

Despite global efforts, the prevalence of obesity continues to rise, with rates in Canada tripling over the past three decades. In addition to the well-established risk of cardiometabolic conditions such as heart disease and diabetes, obesity has been associated with cognitive decline and an increased risk of dementia later in life. Sleeve gastrectomy, the most widely used surgical treatment for severe obesity, has proven effective in promoting significant weight loss and improving overall health. Emerging research, including our recent brain imaging study, suggests that this surgery may also have a positive impact on brain health. Our findings demonstrated significant improvements, with patients experiencing reductions in brain age by 2.9 and 5.6 years 12 and 24 months post-surgery, respectively. Despite these promising results, the long-term effects of sleeve gastrectomy on brain health and cognitive function remains poorly understood. While some patients experience cognitive improvements following surgery, others do not, and the factors driving this variability remain unknown. This proposal aims to comprehensively investigate the impact of bariatric surgery on brain health by examining its cognitive consequences, determinants, and drivers. Understanding the key factors that contribute to brain health improvements after bariatric surgery is essential for optimizing its benefits, preventing relapse and developing personalized interventions to maintain or enhance brain health in individuals living with obesity.

Bariatric Surgery and Pharmacokinetics of Chlorprothixene

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study we investigate the pharmacokinetic effects of bariatric surgery on chlorprothixene.

Bariatric Surgery and Pharmacokinetics of Enalapril

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on enalapril are investigated.

Bariatric Surgery and Pharmacokinetics of Lercanidipine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on lercanidipine are investigated.

Bariatric Surgery and Pharmacokinetics of Gabapentin

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on gabapentin are investigated.

Bariatric Surgery and Pharmacokinetics of Ibuprofen

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on ibuprofen are investigated.

Bariatric Surgery and Pharmacokinetics of Fluoxetine

Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on fluoxetine are investigated.