397 Clinical Trials for Various Conditions
The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological effects by activating glucagon-like peptide-1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) distributed in various organs. These medications provide an average of 15-22% weight reduction in one-year trials, which had not been seen in the past with medical therapy. While the literature suggests that bariatric surgery is superior to these new highly effective medications, there is no head-to-head comparison between the most common bariatric operations (Roux-en-Y gastric bypass \[RYGB\] and sleeve gastrectomy \[SG\]) with semaglutide (once weekly) and tirzepatide (once weekly). The goal of this Randomized Clinical Trial (RCT) is to compare these effective therapies in patients with severe obesity to provide the best evidence to inform clinical decisions in treating patients with obesity.
This clinical trial will test whether preoperative tirzepatide treatment improves outcomes after bariatric surgery. The outcome of this study could impact therapeutic guidelines for the multimodal treatment of obesity. The major objectives are: 1. To evaluate whether pre-operative tirzepatide treatment reduces tissue and circulating inflammatory markers at the time of surgery. 2. To establish the relationship of these changes with postoperative improvements in weight loss, metabolic and inflammatory profiles, comorbidity resolution (glycemic control, blood pressure, lipid profile), and 30-day surgical complications. Researchers will compare data from patients taking tirzepatide to data from patients not taking tirzepatide before their planned bariatric surgery to see if tirzepatide reduces inflammation and improves health outcomes after bariatric surgery. Participants will: Take or not take tirzepatide, depending on what study group they are in, once a week for 3 months. Visit the endocrine clinic once a month for 3 months to be prescribed the drug and for checkups regarding side effects due to the drug. Keep a diary to document taking the drug and any side effects. Continue with their planned bariatric surgery and post-surgery follow-ups according to their healthcare provider.
Adult patients with morbid obesity who have had Roux-en-Y gastric bypass (RYGB) or laparoscopic sleeve gastrectomy (LSG) surgery have impaired drug metabolism. There is a paucity of information available on how these patients metabolize acetaminophen post operatively and if drug preparation has any effect on achieving adequate pain control. The surgery may alter the stomach pH, reduce surface area of the stomach, affect transit time, and alter anatomic and physiologic standard absorption of medications. Due to these anatomic and physiologic changes, we seek to understand the potential effects of liquid versus pill formulations of acetaminophen on pain control in this patient population. The purpose of this study is to assess for subjective and objective measures of optimized pain control between formulations of acetaminophen including oral pills and oral liquid.
To assess the effectiveness of Amisulpride to treat Post Operative Nausea and Vomiting (PONV) and to assess the effectiveness of Amisulpride to prevent PONV following bariatric surgery.
The study plans to learn more about what happens to the body after bariatric surgery in people 12 to 24 years old. The study aims to understand why people respond differently to bariatric surgery and how to define success beyond weight loss alone. The study also plans to learn more about whether a medication (semaglutide) can help people 12 to 24 years old who, between 1 and 2 years after bariatric surgery, have not lost as much weight as expected.
The goal of this clinical trial is to learn if a psychological intervention can increase regular physical activity to help prevent weight regain after metabolic bariatric surgery in adults. The main questions it aims to answer are: 1. Does the psychological intervention increase physical activity? 2. Does the psychological intervention prevent weight regain? 3. Does the psychological intervention increase internal motivation for physical activity and acceptance of the discomfort that can come with physical activity? Researchers will compare the psychological intervention to an educational intervention to see if the psychological intervention works to increase physical activity and prevent weight regain after metabolic bariatric surgery. Participants will: * Complete 12 months of either the psychological or educational intervention. This includes attending online workshops with a small group of participants, completing brief homework assignments, and having individual telephone calls with a counselor. * Wear a device to measure physical activity, use an electronic scale to measure body weight, and complete questionnaires at home on five separate occasions over an 18-month period
The goal of this clinical trial is to evaluate the feasibility and acceptability of a 10-wk hybrid Tai Chi (TC) program with in-person classes and online TC videos among 24 physically inactive adults who are seeking metabolic and bariatric surgery (MBS) in a single-arm trial. The aims are: Aim 1: Feasibility: To evaluate whether TC is feasible, defined as a mean attendance rate of ≥70% in-person TC classes attended. Aim 2: Acceptability: To evaluate whether TC is acceptable, defined as a mean rating of ≥4 across 4 acceptability questionnaire items measured on a 5-point Likert scale (e.g., rate "Tai Chi practice is appealing to me" on a scale from 1 \[completely disagree\] to 5 \[completely agree\]). Participants will complete four individual in-person visits where they will complete study assessments and ten weekly group in-person Tai Chi classes where they will practice Tai Chi with up to 5 other study participants. Additionally, they will be asked to practice Tai Chi at home with the aid of instructional online videos and log their practice.
Roux-en-Y (RYGB) gastric bypass reduces the size and capacity of the stomach and bypasses a portion of the small intestine which leads to decreased food intake and higher levels of a gut hormone called GLP-1 (glucagon-like-peptide-1). These changes lead to weight loss, improved blood sugars and often remission of type 2 diabetes but most patients do not qualify or want surgery. The investigators are searching for ways to make the beneficial effects of RYGB available to most type 2 diabetes patients rather than a select few that undergo RYGB. The investigators believe that parts of RYGB can be medically reproduced through a combination of diet and medicine. Once weekly injectable GLP-1 medicine that leads to weight loss and improved blood sugar control in type 2 diabetes are now FDA approved. Optifast is a medically supervised diet that safely reduces calorie intake to 800 calories per day for three months by replacing normal meals with specially prepared bars and shakes which leads to weight loss and improved blood sugar control in type 2 diabetes. Normal meals are then gradually reintroduced over 6 weeks and the bars/shakes are stopped. The investigators hypothesize that Optifast (diet) + once weekly GLP-1 will lead to weight loss and improvement in blood sugar control in type 2 diabetes similar to what is seen after RYGB.
The goal of this cross-sectional observational study is to examine potential relationships between the blood and gut microbiota of patients with obesity before and after weight loss surgery (WLS) and evaluate potential ethnic differences in the blood and gut microbiotas before and after the WLS. The main aims / objectives of this sub-study are: * Aim 1. Compare the relationship between the blood and the gut microbiomes among a sample of (1) pre-WLS and (2) 6-month post-WLS participants. Hypothesis: Blood bacterial composition will resemble that of the gut microbiome among pre-WLS participants. Because the effect of WLS on the blood microbiome is not known, our post-WLS results will be mostly exploratory. * Aim 2. Determine racial differences in the blood microbiome of the pre- and post-WLS groups. Hypothesis2: Ethnic differences will be detected in both the pre- and post-WLS groups.
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.
Observational two phase, retrospective and prospective registry study to assess the prevalence of and characterize outcomes of autonomic dysfunction (AD) in patients who undergo bariatric surgery (BS) and to better define the underlying pathophysiology of AD following BS.
The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose). Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery. Researchers will compare the effects of walking before bariatric surgery on: * Insulin sensitivity (diabetes risk factor) * Health of blood vessels * Rate of complications after surgery * Weight * Body Fat * Fitness level
The goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy. The main question\[s\]it aims to answer are: * Are there differences in the way that ingested alcohol is handled in men versus women after sleeve gastrectomy? * What is the consequence of drinking alcohol on an empty stomach versus after a meal on blood sugar control after undergoing sleeve gastrectomy? Participants will participate in two types of alcohol tests (alcohol given orally or administered intravenously) after not eating anything overnight or after having a meal. Researchers will compare men and women who underwent sleeve gastrectomy with men and women who had no surgery, are of similar age and body composition, and have similar alcohol intake patterns.
The purpose of this double blind, randomized control trial would be to test the efficacy of a once daily, multi strain symbiotic on gut health changes in weight loss surgery patients by testing stool samples prior to administration and then three months post administration of the symbiotic to monitor any changes in bacteria in the stool samples. Study participants will also complete a survey that evaluates their bowel habits, stool consistency, and gastrointestinal related symptoms.
The goal of this pilot clinical trial is to determine the effectiveness of Tirzepatide in patients with persistent obesity (BMI \> 30) 12 months after bariatric surgery (Roux-en-Y Gastric Bypass). The investigators also aim to determine the frequency of side effects with Tirzepatide in this patient population. Patients who take tirzepatide 12 months after bariatric surgery will be compared to patients who continue with the current standard of care for patients who have previously undergone Gastric Bypass Surgery.
From the research and current studies, post-operative nausea and vomiting is a common complaint after bariatric surgery. Nausea relief inhalers could improve post-operative nausea and vomiting without the need for further medications, subsequently reducing the chance of side effects. This study could help improve patient satisfaction and increase the ability of the patient to ambulate after surgery with the use of a nausea relief inhaler.
This study aims to determine the relationship between lipid kinetics changes and blood immunosuppressive cells by metabolic surgery in two patient cohorts.
This is a randomized controlled trial employing a Sequential Multiple Assignment Randomized Trial (SMART) design to test whether pharmacotherapy, in conjunction with lifestyle counseling, can reverse weight regain after bariatric surgery.
The goal of this waitlist-control design, pilot randomized controlled trial is to test feasibility, acceptability, and preliminary efficacy of a remotely-delivered dyadic positive psychology intervention for patients 2 years after bariatric surgery and their romantic partners (called ReConnect). The main question it aims to answer is whether the intervention results in improvements in depressive symptoms for patients and partners. The additional questions it aims to answer are whether the intervention results in improvements in resilience, relationship satisfaction, eating and physical activity behaviors, and weight maintenance for those in the intervention versus waitlist control condition. Participant couples randomly assigned to the intervention condition will engage in ReConnect for 8 weekly modules and associated positive psychology activities, some individually and some as a couple. Participant couples randomly assigned to the waitlist control condition will wait for 8 weeks to begin the 8 week intervention. All participants will fill out assessment measures at baseline, 8 weeks, and 16 weeks.
The purpose of this study is to better understand the impact of weight-loss surgery on telomere length. Telomeres are a key marker of biological aging of cells. Telomere shortening is a natural process of aging. Several pathologies and lifestyles are associated with premature telomere shortening, such as obesity, diabetes mellitus or sedentary lifestyle. New evidence supports that telomere shortening can be partially reversed by lifestyle changes such as healthy diet, reduced stress, or increased physical activity.
Bariatric surgery is recommended as the most efficacious treatment for patients living with obesity (body mass index \[BMI; kg/m2\] \> 40; or BMI 35-39.9 with related medical conditions). Adoption of telehealth services offers an opportunity to reduce barriers and expand access to high quality specialty care for patients considering bariatric surgery for treatment of obesity. Two important advances in telehealth services occurred during the COVID-19 public health emergency. Specifically, the patient's home is now the origin site for all services where patients are no longer required to travel to a designated telehealth location, and the use of telehealth has expanded to multidisciplinary health care teams. Our bariatric surgery care team has gained valuable experience using a combination of face-to-face (F2F) and telehealth visits for multidisciplinary evaluation in preparation for bariatric surgery since March 2020. Appointments that do not require a physical exam like nutrition, psychology, group education, and medical visits after completion of pre-operative testing are particularly amenable to telehealth services. Increased use of telehealth has the potential to reduce barriers to care (e.g., lack of access to accredited bariatric surgery treatment centers, extended travel time for multiple pre-surgery appointments), increase adherence to required program visits, and increase patient satisfaction. Patient satisfaction variables may include reduced time away from work, flexibility in appointment scheduling, and reduced physical demands of multiple F2F visits. A necessary first step is to demonstrate that the protocol outlined below can be successfully implemented in a real-world clinical setting and is deemed acceptable by patients preparing for bariatric surgery.
Test compliance and gastrointestinal tolerance of a 30-day dose of potato starch in bariatric patients, and determine if short chain fatty acids, specifically butyrate, increase in response to the dosages of potato starch.
To compare the safety and effectiveness of robotic-assisted Duodenal-Switch Bariatric Surgical Procedures (including Biliopancreatic Diversion-Duodenal-Switch/BPD-DS, Single Anastomosis- Duodeno Ileal Bypass with Sleeve/SADI-S, and One Anastomosis Duodenal Switch/OADS) with laparoscopic approaches using real world data (RWD) from the Premier Healthcare Database (PHD).
To investigate if laparoscopic Transversus Abdominis Plane (TAP) block using plain bupivacaine is equivalent to using liposomal bupivacaine in patients undergoing metabolic and bariatric surgery. The study will see if the plain bupivacaine group will be equivalent in terms of length of stay, Morphine Milligram Equivalents, Pain scores and patient satisfaction, but cost less.
The pilot study will be a First In Human Clinical Trial to evaluate the Endolumik Gastric Calibration Tube and associated methods in a human clinical cohort of 20-30 bariatric patients at two high-volume bariatric programs. During this clinical study, the single-use, disposable Endolumik Gastric Calibration Tube will be used during twenty sleeve gastrectomy operations and gastric bypass operations.
The purpose of this study is to Conduct a proof of concept study to assess feasibility, acceptability, and effectiveness of an Metabolic and bariatric surgery (MBS) -supported healthy lifestyle behavioral intervention among adolescent patients, their families, and their clinical team.
This is the Phase 2 pilot/feasibility randomized controlled trial of HALO (Health And Lifestyle Behaviors In Offspring), a parent-led behavioral intervention targeting a high-risk pediatric population (i.e., residing offspring ages 6-12; body mass index \> the 70th and \< 120% of the 95th percentiles of mothers with severe obesity) that is uniquely well-timed, when mothers are highly engaged in behavior change and losing weight during the first year following bariatric surgery.
Study is designed to screen psychological cognitive baseline and retention/improvement after weight loss surgery.
The purpose of this study is to evaluate safety and efficacy of twice-daily ARD-101 in subjects at least one year after bariatric surgery (sleeve gastrectomy or gastric bypass).
This study will compare the effectiveness of behavioral and pharmacologic treatment, alone and combined, for improvements in weight loss, cardiovascular risk factors, and psychosocial functioning following metabolic and bariatric surgery.