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Showing 1-20 of 23 trials
NCT06894498
The objective of this study is to assess the long term weight loss and weight loss journey of patients who received an Endoscopic Sleeve Gastroplasty (ESG) 5 or more years prior to enrollment.
NCT06948058
This project will investigate the effects of alternative nicotine products on smoking, weight gain, and related outcomes.
NCT06734273
This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.
NCT07049861
This project will compare two training approaches for US Preventive Services Task Force recommended obesity care in Federally Qualified Health Centers (FQHC) across four aims. Aim 1 compares patient-level effectiveness \[i.e., patient relative weight change and the proportion of patients who achieve clinically significant weight loss\]. Aim 2 compares reach (patient treatment utilization). Aim 3 compares primary care provider (PCP) referrals to USPSTF-recommended care at 12 (adoption) and 24 months (maintenance) and short- and long-term changes in provider obesity care competencies . Aim 4 compares implementation and service costs.
NCT06795360
The goal of this study is to identify people at risk of weight regain after stopping an injectable weight loss drug. The main question the investigators aim to answer is: Can weight regain be predicted by measuring circulating Agouti-related peptide, a small protein coming from the brain?
NCT07178405
The overall aim of the study is to determine effects of different meal characteristics on energy intake, eating rate and appetite.
NCT06768827
Given the pervasiveness of Pediatric Obesity, it is imperative to understand its pathophysiology and develop alternative strategies to reverse this condition. Herein, investigators propose to elucidate the interaction between colonic fermentation and insulin resistance in modulating metabolism in youth with obesity.
NCT07229924
Background: Obesity is a chronic, systemic, and multifactorial disease affecting populations worldwide, with projections indicating a 50% increase by 2035. It is linked to higher risks of cognitive decline, brain atrophy, and neurodegenerative diseases like Alzheimer's. Bariatric surgery has shown benefits in reducing fat and systemic inflammation, which may improve cognitive function. However, the factors predicting such improvements remain unclear. Objective: To evaluate the effect of bariatric surgery on cognitive performance using virtual reality (Neurotracker) and the Neuropsi neuropsychological battery. Methods: This prospective quasi-experimental study will include patients with morbid obesity who are candidates for bariatric surgery. Cognitive performance will be evaluated using the Neurotracker virtual reality tool and the Neuropsi neuropsychological battery. Participants will complete Neurotracker sessions three times weekly for two weeks before surgery, and again at 3- and 6-months post-surgery. The Neuropsi assessment will be conducted once prior to surgery and repeated at 6 months afterward. Statistical analyses will compare cognitive performance before and after the surgical intervention. Expected Outcomes: The study aims to identify measurable improvements in cognitive function after weight loss from bariatric surgery, evaluated through both traditional neuropsychological tests and immersive virtual reality tools. These results could improve understanding of the cognitive benefits of surgical obesity treatment and the factors that predict these outcomes.
NCT06835933
This study aims to investigate the patterns of reflux symptoms after laparoscopic sleeve gastrectomy based on the presence or absence of preoperative gastroesophageal reflux symptoms.
NCT06859320
Sleeve gastrectomy (SG) continues to be one of the most popular bariatric procedures all over the world. It has been established that obesity is a predisposing factor for several comorbidities, including life-threatening conditions. Many studies have discussed the impact of sleeve gastrectomy on TSH level. But, since most obese patients have some sort of depression, we will try to study the impact of sleeve gastrectomy, depression and hypothyroidism on each other.
NCT07035483
This prospective, single-center observational cohort study aims to explore the relationship between skeletal muscle quality, fat distribution, and metabolic health in Chinese patients with obesity, and to evaluate how bariatric surgery influences these parameters. A total of 120 participants will be enrolled, including 60 patients undergoing bariatric surgery and 60 age- and sex-matched healthy controls. The study involves cross-sectional comparisons of ectopic fat and muscle composition, as well as longitudinal follow-up of surgical patients at multiple time points up to 5 years postoperatively. MRI will be used to quantify regional fat and muscle composition, while metabolic parameters, inflammatory markers, and gut microbiota profiles will also be assessed. Primary outcomes include skeletal muscle mass and fat infiltration, visceral and subcutaneous fat volumes, and changes in insulin resistance. This study seeks to clarify the mechanisms by which bariatric surgery improves metabolic function and to identify early changes in muscle-fat composition that may predict long-term metabolic outcomes.
NCT07034001
The aim of this observational study is to determine the effect of anesthesia on frontal qrs-t angle changes in obese individuals. To learn the long-term effects of intervention A in individuals with a body mass index \> 30 who received intervention A. The main question it aims to answer is: Does frontal qrs-t angle change occur in obese individuals due to anesthesia? Preoperative and intraoperative ECG changes of individuals undergoing surgery will be examined.
NCT06858683
The goal of this randomized trial is to: 1) investigate the immunological landscape of patients with obesity and conduct an in-depth functional characterization of their immune system; and 2) precisely define the effects of time-restricted feeding (TRF) on immune function in patients with obesity; 3) define the immunomodulatory properties of white adipocytes in response to TRF, and 4) uncover the underlying mechanisms by which TRF modulates the immune system patients with obesity through a multi-omics approach. The main questions it aims to answer are: i) what is the underlying cause of impaired immunocompetence in patients with obesity? ii) how nutritional interventions improve the immune function of patients with obesity? Patients with obesity following TRF (8 h eating window ranging from 6-8 am to 14-16 pm) will be compared to patients with obesity without TRF control schedule (14h eating window ranging from 6-8 am to 8-10 pm). The dietary intervention will begin 10 weeks before the scheduled date for bariatric surgery in patients with obesity. In addition to patients with obesity, the present study aims to recruit a group of a reference healthy group (BMI between18.5-24.9 kg/m²) that will not receive any nutritional intervention. The following endpoints will be collected: Body weight and composition using Bioelectrical Impedance Analysis, resting energy expenditure (REE) using indirect calorimetry, blood glucose levels using a continuous glucose monitoring (CGM) device, metabolic parameters (fasting blood glucose levels, C-peptide, HbA1c, insulin, HOMA-IR, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, hepatic enzymes), and cytokine profile. Blood, stool, and white adipose tissue (WAT) samples will be collected to establish metagenomic, transcriptomic, cytomic and metabolomic analyses
NCT06989281
This is a randomized quality improvement project (i.e., not a research study) that will test the implementation and effectiveness of a lifestyle medicine clinic at the University of Alabama at Birmingham.
NCT06932601
Trears Biomarkers: A New Way to Manage Chronic Diseases Trears Biomarkers are changing how we care for chronic diseases by focusing on patients' needs. People with chronic conditions often experience long-lasting changes in their bodies that typical tests do not accurately capture because they mostly measure short-term levels. These tests can be inconvenient, as patients frequently must travel to clinics, and some methods, like using needles, can be painful. The Trears device, on the other hand, is easy and safe for people to use at home. It lets patients take their earwax samples, which they can send to the lab by regular mail, avoiding the hassle of mailing blood samples. This device could even make diagnosing diabetes more accurate. Trears Biomarkers also investigates whether measuring sodium (salt) levels in earwax may be more reliable than a single blood pressure check and more straightforward than using a 24-hour blood pressure monitor. The aim is to enhance the diagnosis of all primary chronic conditions associated with Metabolic Syndrome (MetS), including diabetes, high cholesterol, obesity, and high blood pressure. These conditions are increasingly prevalent and already impact many people worldwide. With just one use, the Trears "multiplex" device could confirm a diagnosis typically requiring multiple tests. Long-term lifestyle changes, like a healthy diet and regular exercise, work better than many drugs for treating MetS. Since the Trears device measures levels that change over time, it can give doctors a better picture of what's happening in a patient's body, allowing for more personalised recommendations. For instance, providing specific dietary advice could be more effective than simply prescribing medication, as it may lead to more lasting improvements in weight and blood pressure. The device's design makes it accessible for home use, including by post, as earwax's natural bacteriostatic properties help preserve sample quality during mailing. In this study, we will test how effectively the Trears device works for diagnosing different types of diabetes and whether it can accurately track long-term levels of MetS markers. The device's new "multiplex" version might also support future point-of-care (POC) testing, allowing for the quick and convenient measurement of all MetS markers. We will consider how lifestyle factors - such as regular earplug use - might affect sample quality, ensuring the technology remains accurate and inclusive across diverse users. If necessary, we will introduce any potential changes in the Trears device design and/or marketing strategy after carefully considering feedback from our patients and their families, as outlined in Trears's mandate. Additionally, we will conduct an economic analysis to determine whether introducing the Trears device to a broader audience is financially sensible and essential. This will strengthen our position when launching our revolutionary technology in a conservative market.
NCT06918405
The goal of this study is to learn if tirzepatide helps people manage their weight safely. It will include adults in Bangladesh who are overweight or obese, with or without type 2 diabetes. The main questions it aims to answer are: Does tirzepatide help people lose weight? What side effects do people experience while taking tirzepatide? All participants will: Receive tirzepatide as a weekly injection, starting at 2.5 mg and gradually increasing to 15 mg. Continue the treatment for 52 weeks (12 months). Visit the clinic for regular checkups and tests. Researchers will measure changes in body weight, BMI, waist size, blood sugar, blood pressure, and cholesterol levels. They will also track any side effects and assess the participants' overall health and quality of life during the study.
NCT06856291
Incretin mimetics are widely used pharmacological treatments for weight loss, known for their high efficacy and favorable safety profile. As the most commonly prescribed drug in this class, semaglutide is effective in both diabetic and non-diabetic individuals. However, treatment responses vary significantly, with non-diabetic individuals typically experiencing better weight loss outcomes. Despite this, up to 10% of non-diabetic individuals show little or no response to treatment, and the reasons for this variability remain unclear. The TRIM-IR study aims to investigate the role of insulin resistance (IR) in weight loss outcomes among non-diabetic obese individuals receiving semaglutide. This single-center, observational study will assess the impact of IR on weight loss, body composition, and adipose tissue function during the first 16 weeks of semaglutide therapy. The study will also explore molecular markers of adipose tissue dysfunction, focusing on the transition from dysfunctional to healthy adipose tissue. The investigators hypothesize, that individuals with lower IR will experience greater weight loss than those with higher IR, and that the glucose infusion rate (GIR) during hyperinsulinemic euglycemic clamp testing will correlate with weight loss variability. Secondary objectives include comparing changes in fat and lean mass, reductions in visceral fat, and improvements in adipose tissue function before and after 16 weeks of treatment. Exploratory analyses will assess adipocyte subpopulations and their response to insulin sensitivity changes. A total of 40 participants, equally distributed by gender, will be enrolled to ensure statistical power for detecting clinically relevant differences. The study aims to optimize semaglutide use for personalized obesity treatment and provide insights into the relationship between obesity, insulin resistance, and adipose tissue plasticity, with implications for improving obesity management and cardiovascular health outcomes.
NCT06885255
The goal of this intervention trial is to assess the effects of intermittent fasting, both alone and in combination with high-intensity interval training, on patients with obesity and metabolic syndrome. The main question it aims to answer is: Does intermittent fasting, with or without high-intensity interval training, reduce chronic inflammation in patients with obesity and metabolic syndrome? Participants will follow an intermittent fasting regime for 3 months, with one intervention group additionally participating in high-intensity interval training twice a week. In addition, there are two control groups: one consisting of participants with metabolic syndrome and one consisting of generally healthy individuals. The study includes a 3-month intervention phase followed by a 3-month follow-up phase. During the 6-month study period, all participants will attend 6 in-house study visits and 2 phone visits, during which they will undergo assessments and receive nutritional counseling.
NCT06857578
The majority of those who undergo gastric bypass surgery have a good/sufficient weight loss, averaging 25-30% after 10-20 years (Adams TD NEJM -18). In a subgroup analysis in LABS, 5% of RYGB patients had an unfavourable weight development with an average of only up to 10% weight loss 7 years after surgery (Courcoulas et al, JAMA Surg -18). These data are in good agreement with data in the Scandinavian quality registry SOReg where 5-10% an insufficient weight loss/weight recurrence 10 years after gastric bypass (SOReg annual report -20). Insufficient weight loss/weight recurrence after gastric bypass can for the individual, in addition to the negative effects on quality of life, mean that comorbidities to obesity are insufficiently controlled or recur. This applies not least to weight-related problems, such as osteoarthritis in the lower extremities where joint replacement surgery can be prevented by too high a body weight. In summary, one in ten patients who undergo bariatric surgery with the gastric bypass method will therefore have an insufficient effect of the procedure in the long term. The first-line treatment is a review of what can be done with diet and exercise, which, however, usually has a very limited effect. In recent years, the addition of medications has become an alternative, but the effect is variable and insufficiently studied over a longer period of time. These medications are also not included in the high-cost coverage. The surgical method that has so far gained the most popularity in gastric bypass reoperation is the so-called "distal gastric bypass". In distal gastric bypass, the part of the intestine where much of the nutrient absorption occurs is so short that all nutrients (fat) are not fully absorbed. Although this method can be effective for weight loss, it often has significant side effects such as diarrhea and deficiencies of minerals and fat-soluble vitamins. Over the past decade, knowledge about the mechanism of action of gastric bypass surgery has increased significantly. It is primarily changes in hunger and satiety signals from the gastrointestinal system to the brain that lead to sustained weight loss. Studies have shown that poorer weight loss is associated with a weaker response to satiety signals compared to those who lose more than average weight, where instead the response is strong. Based on knowledge of the importance of satiety signals, initial experiences have been gained with a new type of revision surgery to amplify the effect in satiety signalling in gastric bypass patients with inadequate weight control. The results of these surgeries have generally been positive, even if not all achieved significant weight loss. This project will systematically study whether a new type of revision surgery is safe and sufficiently effective to achieve the desired weight loss and improve comorbidity in patients who have responded inadequately or regained weight after gastric bypass surgery.
NCT06801496
This study is based on the National Center for Integrated Traditional Chinese and Western Medicine, utilizing the centralized advantages of our department and integrating multiple disciplines (general surgery, endocrinology, nutrition, sports, and traditional Chinese medicine). It focuses on the effectiveness of gastric bypass stents in treating patients with postoperative obesity after laparoscopic sleeve gastrectomy, as well as in patients with simple obesity. This will improve the prognosis of patients and reduce the medical burden.