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Severe Obesity clinical trials

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NCT ID: NCT05409612 Completed - Morbid Obesity Clinical Trials

Trial Assessing the Immunogenicity and Safety of Two Influenza Vaccine Strategies Among Severe Obese Adult Patients

FLUO
Start date: November 7, 2022
Phase: Phase 3
Study type: Interventional

Obesity has been considered as a risk factor for mortality and development of complications during infection with the influenza virus. Several case studies of severe and fatal infections have identified possible effects of obesity on disease progression; these effects include extensive viral replication in the deep lung, progression to viral pneumonia, and prolonged and increased viral shedding. These points may be linked to obesity which causes a chronic state of meta-inflammation with systemic implications for immunity: obese patients exhibit delayed and blunted innate and adaptive immune responses to influenza virus infection, and they experience poor recovery from the disease leading to an increased susceptibility to secondary bacterial infections and poor healing of the lung epithelium. Furthermore, in obese people, influenza virus may exploit the lack of antiviral pressure, generate a more virulent population and increase disease severity Due to the growing prevalence of obesity worldwide (500 million subjects in 2017), it is important to be able to offer vaccines that provide the highest protection for this at-risk population. The quadrivalent recombinant high-dose influenza vaccine has been shown to have greater immunogenicity and efficacy than standard influenza vaccine in non-obese adults older than 50 years. However, this vaccine has never been evaluated in obese subjects. Investigators thus planned this trial to assess whether the use of the new quadrivalent recombinant high-dose influenza vaccine (RIV4) will induce a better immunological answer than current quadrivalent standard vaccine (SD) in patients with severe obesity, with an acceptable safety profile, thus leading to a better protection against influenza in this population at high risk of influenza complications.

NCT ID: NCT05341414 Completed - Clinical trials for Bariatric Surgery Candidate

Trajectories of Resilience and Bariatric Surgery Outcomes

ECLAIRCIE
Start date: May 3, 2021
Phase:
Study type: Observational

A high prevalence of psychological trauma on one hand and of psychiatric disorders, such as depression, anxiety, suicide attempts, addictions, and eating disorders on the other hand, has been reported in patients with severe obesity seeking bariatric surgery. Some studies reported an increased prevalence of these psychiatric disorders after bariatric surgery, potentially related to weight regain. In this context, psychological resilience is a concept that brings together internal and external factors of adaptation, and whose clinical use facilitates interdisciplinary collaborative work. This research focuses on the association between resilience and success or failure of bariatric surgery in patients followed in the Specialized Obesity Center (CSO) of the Nancy University Hospital. The hypothesis is that psychological resilience before surgery promotes successful surgical treatment. This retrospective study is based on existing data from patients with severe obesity who have undergone bariatric surgery at the Nancy CSO. The main objective is to study 1) the resilience of patients with severe obesity, candidates for bariatric surgery, at the first assessment (T0), at the end of lifestyle/behavioral modifications program (T1) and at 2 years after bariatric surgery (T2), 2) the relationship between internal and external factors explaining resilience and final weight outcomes. The investigators are expected that non-resilient patients have more psychological vulnerabilities (psychopathology, negative life events, etc.), and have lower weight loss than resilient patients.

NCT ID: NCT04588610 Completed - Eating Disorders Clinical Trials

Severe Obesity and Eating Habits (OSCAR)

OSCAR
Start date: August 29, 2020
Phase:
Study type: Observational [Patient Registry]

In anorexia nervosa,the eating disorder (ED) is the cause of thinness. In severe obesity, the overweight is a symptom. This symptom, however, is only the consequence of possibly deregulated eating behavior. The literature, focusus a specified ED of DSM-V: Binge Eating Disorder (BED) or Binge Eating, whom estimated prevalence in the severely obese population varies from 1.4 to 49% depending on the studies. The other ED, called unspecified ED (or EDNOS for Eating Disorder Non Otherwise Specified in the English literature), are much less known. The main objective of this study is to assess the prevalence rate of unspecified ED (EDNOS or "non-BED ED") in subjects with severe obesity (BMI> 35) consulting for medical or surgical management in a General Hospital Center CSO (Specialized Obesity Center) using an adapted version of the QEWP-R, called the QEWP-RA.

NCT ID: NCT04129801 Completed - Severe Obesity Clinical Trials

Muscle Strength in Severe Obese Patients in the Postoperative of Bariatric Surgery

Start date: May 5, 2017
Phase:
Study type: Observational

Excessive fat mass (FM) contributes to changes in the strength and endurance of skeletal muscles. Mid-thigh muscle mass is approximately 2.5 times that of fat mass, but individuals who are obese have increased intra- (fat within muscle cells) and intermuscular fat (fat between muscle cells), establishing a negative influence on strength generation capacity and functional independence. The functional capacity of a skeletal muscle can be assessed based on the muscle's ability to produce strength. The relevance of this study is to identify/analyze the changes in segmental body composition (BC) which might better determine the association between fat free mass (FFM) of the lower limbs and maximum voluntary contraction (MVC), 36 months after bariatric surgery. This study was elaborated and will be performed at the Clinical Hospital in the Medical School of the University of Sao Paulo (HCFMUSP). The patients involved will receive the Informed Consent Form. The sample, consists of 155 adults selected at the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP in the periods: preoperative, 6 and 36 months after surgery. Patients of both sexes, above 18 years of age, will undergo bariatric surgery performed at the institution. Adult patients over 60 years old, undergoing revision surgery and other surgical techniques will be excluded. Anthropometric variables will be obtained on the same day as the evaluation of BC by trained evaluators. The BC will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Evaluation of Body Composition and Muscle Strength will be held between 8:00 am and 10:00 am in the Laboratory of Exercise and Movement Studies at the Institute of Orthopedics and Traumatology of FMUSP. BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance. The dynamometer will be used to evaluate muscle strength extension (Ext) and flexion (Flex) MVC torques for both legs will be carried. The MVC assessed variables should be absolute Ext and Flex torques (Nm), Ext and Flex torques relative to the body weight (Nm/Bw) and Ext and Flex torques relative to FFM (Nm/FFM).

NCT ID: NCT04118582 Completed - Severe Obesity Clinical Trials

Resting Metabolic Rate is a Predictor of Weight Regain?

Start date: June 1, 2015
Phase:
Study type: Observational [Patient Registry]

he increasing prevalence of obesity in developed countries has also reached Brazil in the last two decades. Conventional treatments are not efficient to sustained weight loss and in some cases, weight reduction in individuals refractory to these methods. Bariatric surgery has been considered as the most efficient long-term treatment. However, numerous studies have reported weight regain in approximately 20% of patients, from the second year of surgery. The objective of this study is to analyze the changes in resting metabolic rate and body composition before, 6 and 36 months after weight loss and its relation to late weight regain. 48 adults of both sexes, above 18 years, will undergo bypass performed the ambulatory of the Bariatric and Metabolic Surgery Unit of the Department of Gastroenterology of HCFMUSP. Patients over 60 years, undergoing revision surgery and other surgical techniques will be excluded. The body weight (kg) will be measured by In Body 230. BMI (kg/m2) shall be determined by dividing body weight (kg) by height (m) squared. Excess weight (kg): difference in preoperative weight versus ideal weight considered for weight for BMI 25kg/m2. Weight loss (kg): pre-surgery weight difference in relation to the lowest weight reached after 18 months. Percentage of excess of weight loss is difference of weight loss in relation to overweight, used as an indicator of success of surgery. Fat mass (%, kg) and fat-free mass (%, kg) will be obtained by electrical bioimpedance 230, 2.0. For resting metabolic rate, the values of VO2 and VCO2 will be collected by indirect calorimetry using Ultima CPX metabolic analyzer. The daily energy expenditure (kcal/day) will be calculated by the Weir equation. keywords: obesity, resting metabolic rate, body composition analysis, bariatric surgery.

NCT ID: NCT04042493 Completed - Clinical trials for Overweight and Obesity

Connect for Health Pediatric Weight Management Program

Start date: November 19, 2019
Phase: N/A
Study type: Interventional

The overall aim of this study is to disseminate the evidence-based Connect for Health program, specifically targeting pediatric primary care practices that deliver care to low-income children in the US who have a disproportionately high prevalence of childhood obesity and evaluate the effectiveness of the program implementation and dissemination.

NCT ID: NCT03690752 Completed - Severe Obesity Clinical Trials

Adherence to Walking on an Alter G Anti-Gravity Treadmill

Start date: September 9, 2017
Phase: N/A
Study type: Interventional

Several barriers to exercise are present that need to be addressed. Morbidly obese individuals experience more skin friction, urinary stress incontinence, knee pain, low back pain, and hip arthritis than the lean population, which may significantly impair their ability to adhere to an exercise regimen (6). Obesity and overweight also contribute to greater perceived effort, oxygen uptake, and less pleasure during treadmill exercise sessions (7). Recent theories suggest that a negative experience associated with exercise can significantly reduce the likelihood of engaging in future exercise sessions (8). Therefore, tools to reduce these barriers may improve outcomes for exercise-based interventions for morbid obesity. The Alter-G, an antigravity treadmill that alleviates body weight while subjects exercise, has potential to reduce pain and exertion during exercise. Overall, these treadmills have been found to be effective for weight loss in obese populations (10). However, although evidence suggests that the Alter-G would reduce pain and exertion, the effect of the Alter-G treadmill on exercise adherence in morbidly obese populations has not been studied. The hypothesis is that the adherence to and progression of the exercise routine of participants walking at a reduced percentage of their body weight will increase relative to those who must exercise at 100% of their body weight. A secondary hypothesis is that participants who use the Alter-G with the anti-gravity function will experience less pain and perceived exertion during exercise compared to those who exercise at 100% of their body weight. Finally, the investigators hypothesize that increased exercise adherence in those using the anti-gravity function of the Alter-G will lead to increased fitness and improved muscle function.

NCT ID: NCT03638895 Completed - Obesity Clinical Trials

Energy Expenditure From ECAL Indirect Calorimeter in a Multicomponent Weight Management Service

ECAL
Start date: November 28, 2018
Phase: N/A
Study type: Interventional

Whether greater weight loss is as a result of a smaller reduction in energy expenditure with caloric restriction is not known. Resting energy expenditure and 24-hour energy expenditure vary substantially between individuals. In some cases, relatively reduced rates of 24h EE predict weight gain in some populations who have high prevalence of obesity. Obese individuals that lose weight experience a decrease in 24-h EE and resting energy expenditure that is lower than predicted based on changes in body composition. Most weight loss studies have found a large individual variation in the amount of weight change, and whether an individual's response to an intervention can be predicted is not clear. Measurements of 24-hour EE in response to fasting may help predict weight loss. The ECAL indirect calorimeter (ECAL) is a validated device purpose-built to provide the practitioner and patient with energy information that allows for more accurate, reliable method of establishing an obese individuals' metabolic profile. The aim of this study is to determine whether providing energy information from ECAL indirect calorimeter as an adjunct to the multicomponent weight management intervention in non-diabetic obese and severely obese individuals would help predict the response of weight loss.

NCT ID: NCT03529461 Completed - Hypoxia Clinical Trials

Use of Non-Invasive Positive Pressure Ventilation in Patients With Severe Obesity Undergoing Upper Endoscopy Procedures

Start date: April 25, 2017
Phase: N/A
Study type: Interventional

The study evaluated the effect of non-invasive positive pressure ventilation (NIPPV) to decrease the incidence of desaturation events in patients with severe obesity undergoing upper endoscopy.

NCT ID: NCT02959853 Completed - Hypogonadism Clinical Trials

Aromatase Inhibitors and Weight Loss in Severely Obese Hypogonadal Male Veterans (Pilot)

Start date: June 2016
Phase: Phase 4
Study type: Interventional

After the age of 40, there is a gradual decline in the production of testosterone. Among obese men, the decline in testosterone levels is exacerbated by the suppression of the hypothalamic-pituitary-gonadal axis by hyperestrogenemia. The high expression of aromatase enzyme in the adipose tissue enhances the conversion of androgens into estrogens which in turn exert a negative feedback on the hypothalamus and pituitary, leading to the inhibition of production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH), and as a consequence, of testosterone by the testis resulting in hypogonadotropic hypogonadism (HH). Though bone loss is a well recognized side effect of AI in certain populations, such as women with breast cancer, HH obese men present high levels of circulating estrogens that could potentially prevent them from bone loss, estradiol being the main regulator of the male skeleton. This study is designed to determine if aromatase inhibitors in combination with weight loss, compared to weight loss alone, will have a positive effect on muscle strength, symptoms of hypogonadism, and body composition without negatively impacting bone mineral density and bone quality. Results from this study will help determine if certain groups of obese patients would benefit from therapy with aromatase inhibitors.