Clinical Research Directory

Bariatric Surgery Observation Study Part 2

The goal of this observational study is to explore the longterm effects of two bariatric surgical procedures by inviting patients from three public hospitals who had Roux-en-Y gastric bypass or Sleeve gastrectomy to a follow-up after10-15 years The main question\[s\] it aims to answer are: * The duration of the surgical method on weight reduction and remission of comorbidities * Theprevalence of complications and new morbidities after the surgical procedures Participants will be asked be asked to * fill inn questionnaires, * have a clinical examinition * have an interview with nurse and doctor * have blood samples taken * undergo other investigations

Bariatric Surgery for the Reduction of cArdioVascular Events Randomized Controlled Trial

The primary objective of this study is to evaluate if, in patients with severe obesity (body mass index (BMI) ≥30 kg/m2) and high-risk cardiovascular disease (CVD), bariatric surgery compared to medical weight management (MWM) safely reduces the risk of major cardiovascular events. The cost-effectiveness of bariatric surgery will also be examined. Separate sub-studies will be performed to examine the relationship between bariatric surgery and mental health and cognition (BRAVE-Mind), cardiac structure and function, genomics, proteomics and metabolomics.

Determinants of the Long-Term Success of Bariatric Surgery

The management of obesity is based on a multidisciplinary approach and justifies the use of surgery in patients with the most severe forms. Surgery for obesity or bariatric surgery generally allows rapid and significant weight loss however it is associated with significant risks, and its long-term results remain heterogeneous and unpredictable. Long-term data will clarify the role of different types of bariatric surgery in surgical strategy, improve patient information and identify predictors of failure in order to provide personalised and tailored surgery for each candidate .

Effect of Transcutaneous Electrical Nerve Stimulation on PODD in Bariatric Surgery Patients

Researchers aim to evaluate impact of transcutaneous electric nerve stimulator on the incidence of postoperative diaphragmatic dysfunction in patients living with obesity undergoing bariatric surgery

Impact of Weight Loss Induced by Bariatric Surgery or Nutritional Management on Sexual Function in Men With Severe Obesity

Study of the impact of weight loss induced by surgery (interventional group) or optimal nutritional management (control group) on sexual function in men with severe obesity

Preoperative Use of a Magnetically Controlled Capsule Endoscopy in Patients Undergoing Bariatric Surgery

The goal of this clinical trial is to test if a swallowable camera capsule can safely examine the upper digestive tract in people preparing for weight loss surgery. The camera capsule (called NaviCam® Xpress™ Stomach System) is controlled by magnets from outside the body and doesn't require sedation, unlike traditional endoscopy. The main questions it aims to answer are: Can the camera capsule be safely used in people with a body mass index (BMI) greater than 38? Can doctors successfully control and move the camera capsule to see the necessary areas of the stomach and esophagus? Researchers will evaluate 30 participants who are preparing for weight loss surgery. Participants will: Swallow the camera capsule with water after not eating or drinking since midnight Have their upper digestive tract examined while the doctor controls the capsule from outside their body Complete a brief satisfaction survey about their experience Be followed up with a phone call 2-3 weeks after the procedure This study could help determine if the camera capsule is a good alternative to traditional endoscopy for people preparing for weight loss surgery, potentially avoiding the need for sedation.

Gut Microbiome and Sex as Risk Factors for Kidney Stones After Bariatric Surgery

This is a single-center study that aims to better understand how diet and sex affect the risk of kidney stones in people who have had gastric bypass surgery. Subjects will be asked to follow a special (clinic-provided) diet for six days and come to a research clinic for 3 study visits.

Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

As bleeding is a major risk in bariatric surgeries, The study aimed to find any predictors to such bleeding within the surgery or 30 days after surgery. The study is a retrospective study collecting patients data, surgeons data, and hospitals data in order to find if any of the factors influencing patients, surgeons or hospitals, has to do with bleeding in these surgeries and if it does impact bleeding in what way. The goal is finding a predictor that it's neutralizing may prevent bleeding in bariatric surgeries.

CV Imaging of Metabolic Interventions

Cardiovascular disease is the leading cause of death worldwide. It is becoming clearer that heart failure (HF) is closely associated with body's metabolism. Even before the heart becomes weaker, it responds to the stresses by changing the fuels it burns, which results in a reduction in the heart's metabolic efficiency that worsens the heart's condition. Since the heart burns so much fuel and consumes fats and carbohydrates along with other available substrates, any changes in its metabolic efficiency could impact metabolism throughout the body. Specifically, HF is characterized by limited flexibility in substrate utilization leading to an overall energetic deficit. Such energetic deficit is associated with progressive remodeling and alter cardiac hemodynamics. For example, obesity is a widely known risk factor for cardiovascular disease likely lie in how the heart handles energy (substrate utilization and energetics). One commonly recommended treatment for cardiovascular disease, especially coronary artery disease (CAD) or congestive heart failure (CHF), is cardiac rehabilitation. Cardiac rehabilitation for symptomatic cardiovascular disease has been shown to promote a healthy lifestyle, improve physical health and reduce cardiovascular death iii with an apparent dose-dependent response. Participation results in a reduced risk of hospitalization and revascularization procedures, and improved functional status in randomized controlled trials. Thus, cardiac rehabilitation is recommended for individuals with symptomatic CAD or CHF by the American College of Cardiology and American Heart Association. In addition, exercise training in preclinical animal models mirroring the exercise component of cardiac rehabilitation routines have shown increased myocardial regeneration and cardioprotective molecular effects ameliorating adverse myocardial remodeling. Despite these benefits, there is vast heterogeneity in the efficiency of cardiac rehabilitation on the individual level with large variances in improved exercise capacity and cardiac function recovery. Personalization of cardiac rehabilitation necessitates a non-invasive approach to monitor the direct beneficial effects on the heart and more ideally, predict efficacy at baseline. Taken together, understanding how metabolic interventions including bariatric surgery and cardiac rehabilitation change myocardial structure and function is critical for the prevention, diagnosis and prognosis for patients with cardiovascular diseases. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In collaboration with cardiologists at Cleveland Clinic, the investigators aim to study how myocardial microstructure revealed by cardiac MRI changes cardiovascular disease patient population before and after metabolic interventions.

Evaluation of the Stress Response in Anesthesia Use Inhalation Anesthetic (Desflurane) Versus TIVA for Bariatric Surgery

The goal of this clinical trial is to compare the effects of Opioid Free Anesthesia (OFA) with and without volatile anesthetics (in this case desflurane) in patients undergoing bariatric surgery. The main question it aims to answer : -Will there be a difference in the perioperative stress between patients receiving OFA with and without desflurane? Participants will undergoing sleeve gastrectomy or gastric by pass, will be administered OFA with and without desflurane and blood tests (cortisole, ACTH,dopamine, PRL, adrenaline, noradrenaline, lactate) will be collected perioperatively to compare stress in the two groups.

Use of Very Low Calorie Diet Preoperatively to Bariatric Surgery

To investigate use of Very Low Calorie Diet preoperatively to bariatric surgery can optimize weight loss prior to surgery and increase the patients' satisfaction.

Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.

Stepwise PEEP vs Sustained Inflation in Bariatric Surgery Patients

Male and female patients Undergoing laparoscopic bariatric surgeries will be subjected for lung recruitment at end of surgery before emergence from anesthesia by two different methods . to evaluate which might be safer and more effective

Dapagliflozin Effect on Glucose Variability in Patients Post Bariatric Surgery

This study evaluates the effect of SGLT-2 inhibitors (dapagliflozin) on the blood glucose excursions by a continuous glucose monitoring system, the incidence of hypoglycemia and hyperglycemia and change in glycated hemoglobin (HbA1c) level in people had bariatric surgery with and without type 2 diabetes.

RemI for Post-Bariatric Surgery Weight Regain

The goal of this clinical trial is to test the effectiveness of remotely-delivered interventions (utilizing acceptance-based behavioral treatment skills (ABTi)) amongst bariatric surgery populations who are experiencing weight regain postoperatively (\> 5% from their lowest postoperative weight and after postoperative Month 6). Investigators aim to evaluate ABTi's efficacy for reversing weight regain and its effect on targeted weight control behaviors and weight-related comorbidities by comparing participants randomly assigned ABTi (n = 100) to those assigned to a Control group that also receives brief phone calls but that focus on reiterating instruction on the dietary and behavioral changes required of surgery and initially taught preoperatively (C, n = 100). The main research aims are: 1. To compare changes in body weight over 12 months in 200 bariatric patients who have regained \> 5% of their weight and are randomly assigned to ABTi or Control. 2. To compare changes in eating behaviors (i.e., caloric intake, frequency of maladaptive eating behaviors), physical activity, and weight-related comorbidities (i.e., biomarkers of diabetes, hypertension) over 12 months in the two groups. 3. Exploratory - To test ABTi's theoretical mechanisms of action, including a) effects of theory-based active ingredients (i.e., acceptance, defusion, values clarity, mindfulness) on weight outcomes and b) changes in impact of internal states (i.e., hunger, cravings) on eating behavior.

Surgical or Medical Treatment

This study will test the hypothesis that metabolic bariatric surgery will be more effective at providing durable glycemic control and reduce co-morbidities than intensive medical therapy in youth with type 2 diabetes.

Xpan Non-Inferiority Study

A trocar is a surgical instrument with a sharp point and tube and is used to create endoscopic access in the abdomen or chest where endoscopic instruments can be entered \& used in minimally invasive surgical procedures. Xpan has created an FDA Cleared radially dilating trocar (RDT) that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery. The purpose of this research protocol is to demonstrate that a new FDA Cleared Xpan® radially dilating trocar (RDT) system is at least, just as effective as the existing RDT trocar systems. The procedure will be performed using a radially dilating trocar that is inserted at 3mm and can be expanded to 5mm or 12mm during surgery.

Autonomic Neural Blockade in Bariatric Surgery

The purpose of this research is to evaluate if autonomic nerve block (ANB- blocking pain and nausea signals) decreases pain and anti-nausea medication requirements as well as the experience of pain/nausea during the first 72 hours after sleeve gastrectomy or gastric bypass surgery. Participants will be randomly assigned either to the standard of care or the ANB group before surgery. As part of standard of care, in both groups, laparoscopic bariatric surgery will be initiated with local anesthetic injected into the abdominal wall. In the ANB group, participants will be given an additional injection of local anesthetic medication to block nerves on and around the stomach.

Impact of the Use of VERT on Body Image After Bariatric Surgery

The purpose ot the study is to assess the effectiveness of the use of VERT on improving body image at 12 months in patients who underwent bariatric surgery in the weight stabilization phase (between 18 and 30 months after bariatric) presenting dissatisfaction with their body image compared to standard follow-up in post-bariatric surgery (lack of specific management of body image).

Hepatic Energy Fluxes in NASH and NAS Patients

Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States. Bariatric surgery shows great promise in the treatment of these diseases. The studies proposed herein will be the first to measure in humans the relationships among (i) the liver's ability to burn fat and make glucose, two of its primary functions; (ii) the severity of nonalcoholic fatty liver disease; and (iii) the responses to bariatric surgery. These experiments will support deeper future mechanistic investigations of the metabolic mechanisms underlying nonalcoholic steatohepatitis (NASH) improvement with bariatric surgery. The premise of this study is that deranged hepatic mitochondrial metabolism is a key biomarker and mediator of the nonalcoholic fatty liver disease (NAFLD)/NASH continuum, and the central hypothesis the investigators will test is that preoperative hepatic fat oxidation and glucose production flux parameters differ between low versus high NAFLD activity score (NAS), and response of the liver to bariatric surgery can be predicted by preoperative fluxes.

Physiologic and Functional Adaptations of Insulin Sensitive Tissues

The long-term goal is to understand the mechanisms of intestinal nutrient sensing and signal relays to insulin sensitive tissues (adipose, skeletal muscle, liver) in humans. The investigators hypothesize that human tissue biopsies (from obese surgery and non-surgery subjects as well as lean controls) can be used to understand the molecular mechanisms underlying intestinal nutrient sensing and signal relay in humans. The investigator will obtain tissue specimens from patients during scheduled upper endoscopies, colonoscopies and scheduled metabolic and bariatric surgeries or liver transplantation. A blood sample (4mL) will be obtained concurrent with these procedures. From metabolic and bariatric surgery subjects blood and tissues (liver, adipose, small intestine, omentum, skeletal muscle) can be collected at the time of surgery. From liver transplantation patients, excised liver tissue will be collected. Stool can be obtained preoperatively and at various time points after surgery. Some bariatric surgery subjects will participate in a mixed-meal tolerance test at their pre-operative visit and several post-operative visits to compare the whole-body metabolic alterations following bariatric procedures.

Evaluation of the Implementation of a Diet Workshop on the 15th Postoperative Day Following Bariatric Surgery

The objective of the study was to improve protein intake after the implementation of a dietary workshop performed on the 15th postoperative day following bariatric surgery.

Effects of Assisted Robotic vs Laparoscopic Sleeve Gastrectomy

This will be a prospective, obesity-registry based, single-blind randomized controlled trial with a 1:1 allocation ratio. Specific inclusion criteria are all patients eligible to undergo a Laparoscopic sleeve gastrectomy (LSG) based on the current National Institute of Health (NIH) patient selection guidelines. Patients should be able to give consent, be deemed medically-cleared to undergo elective surgery, and tolerate general anesthesia. All enrollments and surgeries in this study will take place at the Cleveland Clinic Bariatric and Metabolic Institute. The study will consist of 2 interventions: laparoscopic sleeve gastrectomy (LSG) or robotic sleeve gastrectomy (RSG). The primary objective is early postoperative pain, but also surgeon ergonomics and patient quality of life will be compared. Additional outcomes include 30-day perioperative results, minor and major morbidities, serious adverse events, resolution of medical comorbidities, and weight loss in percent of excess weight lost (%EWL) at one year.

Surgery Versus Best Medical Management for the Long Term Remission of Type 2 Diabetes and Related Diseases (REMISSION)

Bariatric surgery procedures induce weight loss through restriction and/or malabsorption. The mechanisms underlying type 2 diabetes remission and others metabolic improvements after Roux-en-Y Gastric Bypass (RYGB), sleeve gastrectomy (SG) or biliopancreatic diversion with duodenal switch (BPD-DS) have not yet been formally studied. The investigators propose a longitudinal study with the overall objective of measuring the long-term impact of these three bariatric surgeries (RYGB, SG, BPD-DS) on metabolic, renal and cardiovascular fate in patients with type 2 diabetes. The investigators overall hypothesis is that some bariatric procedures generate hitherto unrecognized effects on many disease-related outcomes, which greatly contributes to their beneficial impact in diabetic patients. The investigators propose 3 specific aims: 1) to establish the long term effect of the three surgeries on the metabolic recovery and quality of life in groups of diabetic patients treated with insulin, hypoglycemic agents or diet; 2) to establish the long term impact of the three surgeries on renal and cardiovascular functions in subgroup of patients with these conditions; 3) to compare metabolic impact of surgeries to those of best medical care for diabetes in a non-surgical control group. For most severely obese patients, lifestyle interventions, perhaps effective in inducing short-lived weight losses, are ineffective for long-term weight loss maintenance and durable metabolic recovery. The increasing popularity of obesity surgeries calls for a better understanding of the underlying mechanisms. This is especially true and urgent when considering that knowledge on the relative impact of each procedure (i.e. SG vs. RYGB and BPD-DS) in resolving T2D is still limited. Better knowledge on each of the procedures will allow stronger scientific rationale for selecting the right surgery for the right patient and improve care for the severely obese individual.