Active clinical trials for "Obesity"

Obesity is a medical problem of epidemic proportions and is associated with high mortality. Obesity has significant effects on the cardiovascular system, producing structural cardiovascular changes including myocardial hypertrophy, fatty infiltration, and fibrosis; diastolic and systolic dysfunction; changes in pulmonary artery compliance; and increased aortic stiffness - all of which can lead to heart failure. Indeed, evidence suggests that obesity increases the risk for heart disease independent of other known risk factors such as coronary artery disease, hypertension, diabetes mellitus, and obstructive sleep apnea. Obesity also causes significant changes in pulmonary function, including a decrease in expiratory reserve volume and functional residual capacity and closure of peripheral airways. The exact mechanisms for the development of cardiopulmonary disease are not well understood - the pathophysiology is complex and likely multifactorial, related to altered hemodynamic load, altered metabolic activity, underlying inflammation, and increased cardiac output. Newer diagnostic modalities available at our institution such as cardiac MRI and pulmonary function tests with impulse oscillometry allow us to better evaluate cardiopulmonary dysfunction in patients with severe obesity. Cardiac MRI is especially promising as a non-invasive imaging modality in obese individuals, providing more reproducible measurements of cardiac and vascular anatomy and function relative to echocardiography. Similarly, pulmonary function testing with impulse oscillometry is more sensitive for detection of abnormalities in the distal airways especially when spirometry is normal, as frequently occurs in the severely obese symptomatic patients. The main objective of the proposed study is to evaluate the effect of obesity on quality of life and health care utilization and its relationship to cardiopulmonary disease in an ethnically diverse, underserved obese population by using state-of-the-art diagnostic modalities before and after significant (20%) weight loss. The investigators propose to perform stress cardiac MRI and pulmonary function testing with oscillometry before and after significant surgical weight loss in 150 severely obese patients with cardiopulmonary symptoms. Patients evaluated in the comprehensive Obesity Center at Bellevue Hospital who meet NIH Consensus Guidelines for Bariatric Surgery, who have cardiopulmonary symptoms, and who meet clinical criteria for cardiac stress testing and pulmonary function testing will be approached by the study personnel and offered enrollment. Informed consent will be obtained. Enrolled patients will undergo clinical evaluation with a detailed medical history including the Borg dyspnea scale, physical examination, laboratory testing including cardiopulmonary biomarkers (brain natriuretic peptide, C-reactive protein, atrial natriuretic peptide), and non-invasive cardiovascular stress MRI and pulmonary physiologic evaluation including spirometry, plethysmography and impulse oscillometry (IOS). Patients with active smoking history and/or asthma will be identified clinically. Cardiovascular MRI will be performed using a 1.5T (Avanto or Espree, Siemens Healthcare) system. Standard cardiovascular techniques will be used for the assessment of myocardial and vascular structure and function, including T1-weighted, T2-weighted, late gadolinium enhancement, cine, tagged and phase contrast imaging in selected planes. Adenosine stress MRI will be performed for evaluation of underlying coronary artery or microvascular disease.

Obesity and its associated conditions have reached epidemic proportions. Estimates are that about one third of the adults in the United States have obesity. At this moment there are many therapeutic approaches for the treatment of obesity. But, efficacy of most treatment options are limited and so far surgical intervention has been proven to be the only strategy to overcome severe obesity. However, bariatric surgery has limitations and risks, which might be minimized by non-incisional endoscopic procedures. BaroSense developed a new device, called the Articulating Circular Endoscopic (ACETM) Stapler, which can be used in the treatment of obesity. It is a trans-oral procedure, which intends to reduce the ability of the stomach to expand by creating plications in the region of the fundus and greater curvature. In contrast with other bariatric surgery it is endoscopically performed, reversible and if it fails most future surgical options are still open. The main study ('Open, prospective study to evaluate the safety and preliminary effectiveness of the BaroSense ACE™ Stapler for the treatment of obesity', multicenter study (MUMC+, AMC and St. Antonius), accepted by MEC AMC) seeks to determine the safety and efficacy of this plicating system for patients with severe obesity. In this sub-study the investogators want to unravel the exact mechanism and provide more information about the efficacy of the BaroSense ACE™ Stapler. Therefore the authors will measure changes in various parameters that are known to affect weight loss and metabolism, before and after gastric plication (by using the BaroSense ACE™ Stapler) in overweight subjects (these parameters will only be measured in patients at MUMC+). These parameters are post-prandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, satiety hormone release, microbiota composition and inflammatory markers. Objectives: Aim of the present study will be to assess the effect of the BaroSense ACE™ stapler on postprandial satiety, food-reward and related brain signalling, gastric emptying, behaviour towards food, food intake, hormone release, microbiota composition and inflammatory markers.

This study has been designed to study differences bone turnover in relation to glucagon-like peptide-2 (GLP-2) following feeding in lean and obese premenopausal women. Given the preliminary evidence that GLP-2 may act directly on osteoclasts, the investigators plan to determine whether GLP2 receptors are expressed in osteoclasts and the effect of GLP-2 on bone resorption. Hypotheses: Acute responses of GLP-2 and bone resorption markers following feeding are affected by body fat mass. Serum levels of GLP-2 are lower in obese pre-menopausal women and are associated with a reduction in trabecular and/or cortical bone mass GLP-2 has direct actions on osteoclast resorption via a functional receptor

Obesity and Type 2 Diabetes Mellitus are major health problems which are becoming a burden both for patients and health systems alike. The surgical and medical treatments available for these conditions have improved significantly in the last two decades. The investigators do not however know how these treatments compare to each other and how they act in the body to cause weight loss and diabetes improvements. The studies of this experiment are complementary to each other. They aim to answer related questions and will allow us to study how these treatments work and eventually develop safer and more effective therapies for obesity and diabetes.

This is a pilot project in which investigators will recruit obese (pre-pregnancy BMI of ≥ 35 kg/m2) women from the newly developed "My Clinic" at London Health Sciences Centre as well as normal obstetrical care at London Health Sciences Centre. Patients will be randomized to one of three treatment groups: 1) the full Nutrition and Exercise Lifestyle Intervention Program (NELIP), 2) Nutrition program only, or 3) Exercise program only. The investigators hypothesize that the evidence-based NELIP for obese pregnant women will be feasible to adopt in a clinical setting and will prevent excessive gestational weight gain, gestational diabetes and promote healthy infant growth patterns at the 6 and 12 month milestones. Outcomes may be improved in My Clinic over normal obstetrical care patients with interprofessional services.

The waist circumference (WC) cut off levels of the Caucasian people may not represent the characteristics of different ethnic groups. The investigators aimed to determine sex specific WC cut off points to predict obesity, metabolic syndrome and increased cardiovascular risk in Turkish adults.

This is a pilot community-based research study to examine the effects of specific environmental and social factors on physical activity, fitness, and health of middle school Hispanic children living in an inner-city community.

The project aims at assessment of the effect of the FTO gene polymorphism and the type of treatment on the development of overweight/obesity and features of metabolic syndrome in children with type 1 diabetes. Gene polymorphism including some genetic variants may predispose to the development of cardiovascular diseases and their complications. The A allele of the FTO gene predisposing to obesity occurs in approximately 40% of the European population and each copy of this allele can increase BMI by 0.1 Z-score i.e. by 0.4 kg/m2. Insulin therapy in diabetic patients may result in excess body weight gain. Therefore we need studies involving large groups of children and assessing cardiovascular risk factors in type 1 diabetes along with their genetic associations. Patients: The study will include 1500 children with type 1 diabetes, aged 6-18 years. Reference group will be made of 1500 children in whom type 1 diabetes was excluded. The following variables will be assessed in the treatment group: 1) Anthropometric data and questionnaire data: age, sex, body height and weight, body mass index (BMI), waist and hip circumferences, arm and thigh circumferences, family history of overweight/obesity, type 1 or 2 diabetes or cardiovascular disease, 2) Primary disease characteristics: age of the disease onset, treatment regimen, mean daily insulin consumption per kg body weight, brands of insulin products, glycated haemoglobin, BMI from the first 3-6 months following diabetes onset, diet, conversion of these data into actual and ideal calorie intake 3) Laboratory data - lipid profile and blood pressure (average of three measurements). Methodology: Gene polymorphism analysis in the extracted DNA will be made with the real-time PCR method using TaqMan 7900 HT by Applied Biosystems. Correlations between the FTO gene polymorphism and clinical variables such as BMI (including BMI increase since the disease onset), body weight and height, waist and hip circumferences, arm and thigh circumferences, and blood pressure will be assessed by a professional statistician with a specially dedicated software. Moreover parameters such as diet and metabolic control will be assessed. As regards insulin therapy the following variables will be analysed: insulin injection device, therapy regimen (intensive versus functional; brands and types of insulin products: human insulin versus insulin analogue), consumption of insulin. All of the above listed variables will be correlated with the genotypes found in the gene polymorphism analysis. The study has been approved by Bioethics Committee of the Medical University in Białystok. Results: The authors of the project expect that the effect of the FTO gene polymorphism on overweight/obesity and features of metabolic syndrome in children with type 1 diabetes will be shown. Moreover the project will enable assessment of the effect of the therapeutic regimen, including the type of insulin product, on body weight increase in the course of type 1 diabetes treatment in the context of the FTO gene polymorphism. Confirmation of the above associations and identification of a group at risk of excess body weight increase in the course of insulin therapy may help physicians, parents and patients to avoid this complication. Therefore clinical benefit of this project will include identification - based on the genetic assays results - of a group of type 1 diabetic children particularly likely to develop overweight, obesity and other cardiovascular risk factors.

The aim of this study focuses on obtaining accurate information on the effectiveness of interventions involving physical activity and/or nutrition education developed in the school environment. This study is intended to assist in future assembly and development of effective school practices related to preventing and reducing levels of overweight in children and adolescents. Updated data from the systematic review: 5,899 studies were retrieved in 14 databases (Assia, Central Cochrane, CINAHL, EMBASE, ERIC, ISI, LILACS, Physical Education Index, PsycINFO, PubMed, Social Care Online, Social Services Abstracts, Sociological Abstracts, SPORTDiscus) 1,228 were excluded as duplicates by Eppi Reviewer 4,678 studies referred for evaluation by title and abstracts (4,671 by systematic searches, 7 by cross-references list) 211 full text papers reviewed by EPHPP and GRADE tools 140 studies with data extracted Body Mass Index Results: Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. The effect of school-based physical activity interventions on body mass index: a meta-analysis of randomized trials. Clinics (Sao Paulo). 2013 Sep;68(9):1263-1273 - Isolated Physical Activity interventions: 0.02 (95%CI: -0.13, 0.17; 11 trials; n=4,273; I2=77%) Silveira JA, Taddei JA, Guerra PH, Nobre MR. The effect of participation in school-based nutrition education interventions on body mass index: a meta-analysis of randomized controlled community trials. Prev Med. 2013 Mar;56(3-4):237-43 - Isolated Nutrition Education interventions: -0.33 (95%CI: -0.55, -0.11; 8 trials; n=8,491; I2=95%) Guerra PH, Nobre MRC, Silveira JAC, Taddei JAAC. School-based physical activity and nutritional education interventions on body mass index: a meta-analysis of randomized community trials - Project PANE (manuscript under review) - Combined Physical Activity and Nutrition Education interventions: -0.03 (-0.09, 0.04; 38 trials; n=28,870; I2=83%) / All interventions included: -0.03 (95%CI: -0.09, 0.03; 55 trials n=41,634; I2=87%)

This study presents evaluates the effectiveness of the Healthy Opportunities for Physical Activity(HOP'N) After-School Program on preventing obesity in children. The investigators hypothesized that normal and overweight/obese children attending after-school sites randomized to the control condition will increase in weight status to a greater extent compared to children at sites randomized to receive the HOP'N program. The investigators also hypothesized that after-school intervention HOP'N sites will increase in physical activity and healthful eating opportunities compared to control sites.