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Obesity, Morbid clinical trials

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NCT ID: NCT06346145 Not yet recruiting - Heart Diseases Clinical Trials

Impact of Bariatric Surgery on Heart Disease Compared to Standard Care

MIMS
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Obesity is associated with type 2 diabetes (T2D) and cardiovascular disease (CVD). Metabolic and bariatric surgery (MBS) has in several randomized controlled trials (RCT) been shown to be superior to best medical therapy in the treatment of T2D. In the area of CVD, RCT after MBS are lacking. It was recently demonstrated in a cohort study that MBS in patients with severe obesity and a previous myocardial infarction (MI) was associated with a 50% reduction in the risk of death and new MI. The aim of this proposal is to confirm this in a nationwide RCT. Using the nationwide SWEDEHEART database patients with severe obesity and a previous MI will be identified. They will be contacted and offered participation. After informed consent the patients will be randomized to MBS or optimized care (including visit with a cardiologist and optimization of secondary preventive measures and referral to dietician/physiotherapist). The primary outcome measure is a major cardiovascular adverse event (MACE). Secondary outcome measures include mortality, new MI, stroke, heart failure and atrial fibrillation. Tertiary outcome measures include health related quality of life and surgical complications. Patients will be followed in the nationwide metabolic surgery register SOReg, the national inpatient register, national cause of death register, the Swedish prescribed drug register, and the Swedish population register. If positive results these can be included in guidelines for MBS.

NCT ID: NCT06299644 Not yet recruiting - Obesity Clinical Trials

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Start date: May 1, 2025
Phase: N/A
Study type: Interventional

The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.

NCT ID: NCT06298942 Not yet recruiting - Obesity, Morbid Clinical Trials

Naturally Banded Versus Synthetic Banding of Sleeve Gastrectomy

Start date: March 15, 2024
Phase: N/A
Study type: Interventional

to compare banding sleeve gastrectomy using silicone ring Versus using natural flap ( round ligament of the liver)

NCT ID: NCT06287632 Not yet recruiting - Obesity, Abdominal Clinical Trials

CPAP in Patients With Severe Obesity After Anesthesia

Start date: June 2024
Phase: N/A
Study type: Interventional

The goal of this study is to compare two continuous positive airway pressure (CPAP) settings on heart and lung function in patients with severe obesity after anesthesia. The main questions it aims to answer are: 1. Does a recruitment maneuver and CPAP set to intrathoracic pressure (ITP) improve cardiopulmonary function compared to standard CPAP settings in patients with severe obesity after anesthesia? 2. Does the location of adipose tissue influence the response to CPAP settings in patients with severe obesity after anesthesia? Participants will undergo monitoring of their intrathoracic pressure using an esophageal catheter. In the recovery area after anesthesia, participants will receive two CPAP settings, each for 20 minutes. - Intervention 1: Recruitment maneuver and CPAP will set to the level of intrathoracic pressure - Intervention 2: CPAP set to home settings (if OSA is present) or between 8-10 cmH20 (if OSA is not present).

NCT ID: NCT06287307 Not yet recruiting - Obesity Clinical Trials

Semaglutide 2.4mg for Low Responders After Bariatric Surgery

SEABAR
Start date: May 2024
Phase: Phase 4
Study type: Interventional

In 20 - 30% of the patients, the low responders, sufficient weight loss is not achieved after bariatric surgery. Secondary and/or tertiary bariatric procedures can lead to successful weight loss and resolution of comorbid conditions though, morbidity and mortality rates of these procedures are high. Therefore, additional pharmacotherapy has been suggested. Semaglutide is one of the medications that might improve outcome in the post-bariatric population. Semaglutide is a Glucagon-like peptide-1 (GLP-1) receptor analogue developed to treat type 2 diabetes. It causes glucose-dependent insulin secretion, promotes satiety and inhibits glucagon secretion. In obese (non-bariatric) patients, semaglutide has shown to improve glycemic control, decrease blood pressure, lower cardiovascular risk, and decrease body weight.

NCT ID: NCT06200961 Not yet recruiting - Obesity Clinical Trials

Trans-nasal Endoscopy for Bariatric Patients

TNE
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

This study plans to learn if the EvoEndo Endoscopy system can be used to evaluate, provide and follow up care for upper gastrointestinal tract diseases in the bariatric population. The smallest current scope available for such a technique is an adult transnasal endoscope with a larger diameter, a pulmonary bronchoscope or Ear Nose and Throat (ENT) laryngoscope. This study is evaluating a newly Food and Drug Administration (FDA) cleared ultra-slim, single-use, endoscope specifically designed for transnasal endoscopy to evaluate its use in adult upper tract gastrointestinal diseases. If such a technique is successful it could improve the safety, cost, and access of endoscopic care for patients in need of an endoscopic evaluation for a bariatric medical condition.

NCT ID: NCT06199154 Not yet recruiting - Pregnancy Clinical Trials

Induction of Labor in Morbidly Obese Patients

Start date: May 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this randomized control trial is to compare different doses of Misoprostol (25 mcg vs 50 mcg) in induction of labor (IOL) in morbidly obese patients with BMI >40. It is known that morbid obesity is a risk factor for failed IOL and ultimately cesarean delivery (CD.) If the rates of vaginal delivery in this population can improve, then surgical morbidity can be reduced in these patients.

NCT ID: NCT06181279 Not yet recruiting - Obesity, Morbid Clinical Trials

Effects of Individualized PEEP Guided by Driving Pressure on Postoperative Atelectasis in Patients With Morbid Obesity

Start date: April 1, 2024
Phase: N/A
Study type: Interventional

Atelectasis is a common complication in patients undergoing surgery under general anesthesia, particularly in obese patients. Postoperative atelectasis could last for more than 24h and contribute to a variety of other complications, including hypoxemia and pneumonia. We plan to conduct a single-center, randomized controlled trial in patients undergoing bariatric surgery to test the hypothesis that driving pressure guided PEEP could reduce the postoperative atelectasis.

NCT ID: NCT06171152 Not yet recruiting - Obesity Clinical Trials

Study of Liraglutide (A Weight Loss Drug) in High Risk Obese Participants With Cognitive and Memory Issues

Start date: April 1, 2024
Phase: Early Phase 1
Study type: Interventional

This study is for people who have multiple sclerosis, acute leukemia (in remission), or long-COVID and a Body Mass Index over 27 and may struggle with cognitive issues such as remembering information, concentrating, or making decisions that affect everyday life. By doing this study, researchers hope to learn how liraglutide (Saxenda®), a weight loss drug, affects levels of a certain disease marker in the body called Brain Derived Neurotrophic Factor (BDNF). Participation in this research will last about 21 weeks.

NCT ID: NCT06162715 Not yet recruiting - Severe Obesity Clinical Trials

GLP-1 Receptor Agonists Post-Bariatric Surgery (GRABS) Feasibility Trial

GRABS-0
Start date: May 2024
Phase: Phase 2/Phase 3
Study type: Interventional

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). We 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 receive a placebo.