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Obesity, Morbid clinical trials

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NCT ID: NCT05840705 Recruiting - Obesity, Morbid Clinical Trials

Approach Modification for Total Knee Arthroplasty in Morbidly Obese Patients

Start date: January 1, 2018
Phase: N/A
Study type: Interventional

The study provides a detailed description of a smaller incision with better visualization in total knee arthroplasty operations

NCT ID: NCT05832190 Recruiting - Metabolic Syndrome Clinical Trials

Correcting GUT microbioTa by Combined Supplementation of fibERs and bIotiN to Improve Microbiome and Optimize Bariatric Surgery Outcomes

GUTERRING
Start date: July 24, 2023
Phase: N/A
Study type: Interventional

Bariatric surgery improves health outcomes with a maximal weight loss on average occurring 1 year after surgery but with dramatic between-subjects variability in weight loss (ranging from 20 to 160% excess weight loss) for reasons that remain to be elucidated. The investigators hypothesize that targeting the 3 months pre-surgery period by a calibrated dietary intervention, with fiber enrichment and biotin, will improve gut microbiota richness and subsequently improve subjects' metabolic health that may optimize post bariatric surgery outcomes. The study is designed as a pilot, comparative, randomized, open-label trial with 4 arms: standard of care, biotin only, fibers only, biotin + fibers.

NCT ID: NCT05816798 Recruiting - Obesity, Morbid Clinical Trials

Photobiomodulation in Chronic Knee Pain in Patients Who Are in PreRehabilitation for Bariatric Surgery

Start date: July 28, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

Chronic pain is a global public health problem, which intensifies even more in the obese population, reaching about 33% of these patients. Among the topography, chronic knee pain affects 80%, constituting an important cause of disability and decreased quality of life. In addition, in grade 3 obesity, also called morbid obesity, in which bariatric surgery is already indicated, knee pain makes it difficult or prevents participation in the pre-habilitation program that includes physical therapy through therapeutic exercises with the aim of reducing postoperative complications. In this sense, a double-blind, randomized, placebo-controlled clinical trial will be conducted with the objective of evaluating the effect of photobiomodulation (PBM) on pain and functionality of obese patients with chronic knee pain who are in a prehabilitation program for bariatric surgery, discussing its role as an analgesic therapy and modifier of peripheral and central sensitization mechanisms of the pain pathway. PBM is a safe treatment option, with no undesirable effects and low cost. The primary outcomes will be pain intensity, through visual analogue scale, and Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire, validated version for Portuguese - Brazil. Secondary outcomes will be pressure pain threshold and rolling pinch maneuver measured by digital algometer. Other exploratory outcomes will be 6-minute walk test, knee range of motion, SF-36 quality of life questionnaire. There will be 2 groups: an intervention group (photobiomodulation associated with standard physiotherapy treatment) and another placebo group (device turned off associated with the same standard physiotherapy treatment). The application sites will be knees and lumbar paravertebral 2 times a week for 12 weeks. The dosimetric standards will be 4J/point in the knees and 3J/point in the lumbar. The results obtained will be statistically analyzed and later published in a scientific journal.

NCT ID: NCT05816031 Recruiting - Obesity, Morbid Clinical Trials

Effect of Ketogenic Diet on Peri-operative Complications of Right Laparoscopic Adrenalectomy in Obese Patients

Start date: January 1, 2020
Phase:
Study type: Observational

Ketogenic diet is often prescribed to morbid obese patients scheduled for bariatric surgery in order to reduce liver size, thus making surgery less demanding. The study aim to investigate the possible effects of ketogenic diet on intra- and peri-operative complications of right laparoscopic adrenalectomy in obese patients; researchers will analyze intra- and peri-operative outcomes among obese patients who underwent laparoscopic right adrenalectomy, comparing the two arms with and without ketogenic diet.

NCT ID: NCT05786092 Recruiting - Severe Obesity Clinical Trials

Impact of Telemonitoring on Metabolic Variables in Severe Obesity

teleob
Start date: September 15, 2020
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare, in a population of severely obese patients, two different kinds of follow-up after discharge from in-hospital rehabilitation programme. The main questions addressed are: - primary outcome: comparing the dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up. - secondary outcome: comparing the amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits. Participants are given a set of instruments (scale, activity tracker, automatic blood pressure monitor, oxymeter, and glucometer) and asked to measure vital parameters following a predetermined schedule for one year. Subjects are asked to engage in regular physical activity and follow the nutritional guidelines received at the moment of discharge from hospital.

NCT ID: NCT05783466 Recruiting - Morbid Obesity Clinical Trials

Dairy Lipids and Cardiometabolic Risk

DAILICATE
Start date: June 28, 2023
Phase: N/A
Study type: Interventional

It is a randomized parallel arm intervention study in adults with severe obesity. The objective is to demonstrate that within a dietary handling for weight loss, the daily ingestion during 3 months of whole dairy products enriched with milk polar lipids or whole dairy products decreases to a greater extent fasting plasma apolipoprotein B concentrations than the daily ingestion of low-fat dairy products (control group). Metabolic parameters will be assessed before and after the 3-month intervention, both at fasting and in postprandial period after the consumption of standardized meals.

NCT ID: NCT05781269 Recruiting - Obesity Clinical Trials

Long Term Effect of Very-low-calories Ketogenic Diet on Weight Control and Cardiovascular Brisk Factors (KETOHEART)

KETOHEART
Start date: February 20, 2022
Phase: N/A
Study type: Interventional

The growing obesity pandemic has a major impact on global cardiovascular (CVD)-related morbidity and premature mortality, severely compromising the quality of life of those affected and significantly increasing costs for the healthcare system. Numerous scientific evidences have demonstrated that a moderate weight loss (5-10% of the initial body weight) is already sufficient to determine the improvement of the cardiometabolic risk factors associated with overweight and obesity. With a view to obtaining a more significant weight loss in the initial stages of dietary treatment, in the last 10 years, the very low-calorie ketogenic diet (VLCKD) has become a strategy for the treatment of obesity and its comorbidities, also allowing to limit therapeutic failure and the high drop-out typical of traditional low-calorie diets. The present study aims to study the long-term efficacy (36 months) of VLCKD in patients with severe obesity and metabolic syndrome, on weight loss, on single factors of the metabolic syndrome compared to a restrictive Mediterranean diet. One hundred subjects with severe obesity and metabolic syndrome will be recruited and randomly assigned to VLCKD or to restrictive Mediterranean diet. Anthropometric parameters, metabolic status blood pressure, degree of arterial stiffness, prevalence and severity of snoring and OSA, cardiac systolic and diastolic function, the autonomic nervous control mode of the circulation will be evaluated at baseline, after one month and at the end of the study.

NCT ID: NCT05777928 Recruiting - Obesity, Morbid Clinical Trials

Bariatric Surgery and Modulation of Perceived Satiety

BAR_SAZ
Start date: June 3, 2021
Phase: N/A
Study type: Interventional

Bariatric surgery is the ideal therapeutic strategy for patients with severe obesity when lifestyle interventions have failed. Unfortunately, weight recovery after surgery affects one third of patients and is due to several factors, such as recovery of incorrect eating behaviour, reduction of physical activity or hormonal factors. Dilation of gastro-jejunal anastomosis is one of the main causes as it determines reduction of satiety in the patient and consequent increase of the portions of food consumed. In these cases it is necessary to make a review of gastro-jejunal anastomosis and to reduce surgical complications in recent years has been developed a method that allows the execution of sutures through a totally endoscopic way (OverStitchâ„¢ Endoscopic Suturing System). Literature studies to assess hunger-satiety in patients undergoing bariatric surgery, suggest that surgery results in weight loss due to a series of changes in gastrointestinal physiology which impact on the feeling of hunger-satiety, and on the modification of the secretion of hormones involved in the regulation of gastric emptying such as the reduction of ghrelin secretion and the increase in postprandial cholecystokinin and GLP-1. There are no data in the literature on satiety in patients in previous bariatric surgery with weight recovery secondary to dilation of the gastro-jejunal anastomosis. There are various methods to assess satiety, most of which are invasive and difficult to perform in routine clinical settings. A recently proposed method to evaluate the perception of satiety and validated on healthy adults, is the Water Load Tests (WLTs). The test consists in making the subject drink a quantity of water until he feels "pleasantly" full. The volume of water ingested is a valid indicator of the subjective feeling of satiety. The aim of yhe study is to assess perceived satiety (measured by Water Load Test) after intervention of Sleeve Gastrectomy or a revision surgery with OverStitchâ„¢ Endoscopic Suturing System in obese individuals suitable for bariatric surgery

NCT ID: NCT05767177 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Jejunal Ketogenesis and Type 2 Diabetes

But2
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

The goal of this cross-over study in obese subjects is to learn about the common co-morbidity type 2 diabetes and the local formation of ketone bodies. The type of study is an exploratory trial with the participants as own controls. The main questions it aims to answer are: 1. Does food intake-induced ketogenesis exist in the small intestine of obese individuals? 2. Are insulin resistance, the incretin GLP-1 release and the glucose transporter SGLT1 affected in obese individuals without type 2 diabetes in the same way as those with type 2 diabetes?

NCT ID: NCT05763394 Recruiting - Obesity Clinical Trials

Effects of Polarized Exercise in Adolescents With Severe Obesity (ALPOLAROB)

ALPOLAROB
Start date: July 4, 2022
Phase: N/A
Study type: Interventional

Recent studies have shown that polarized training (i.e. the combination in the same session of intermittent high intensity exercise training, consisting of repeated, short-duration, high-intensity exercises on a cycle ergometer or a treadmill, and moderate exercise) can encourage the participation of obese people in body weight reduction programs, providing more dynamic exercises, less tiring and therefore more acceptable. To date, no data are available on the effects of polarized exercise in the rehabilitation of obese adolescents, who are often unwilling to engage in prolonged and monotonous motor activities. The demonstration that the polarized exercise might encourage the participation of obese adolescents in multidisciplinary body weight reduction programs, improve the cardiovascular capacity and also favor an adequate oxidation of lipids during the phase of exercise and post-exercise rest, could support its prescription in the programs of integrated metabolic rehabilitation of adolescent obesity.