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Obesity clinical trials

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NCT ID: NCT03555110 Recruiting - Obesity Clinical Trials

Effects of EMDR Therapy in Patients With Severe Obesity

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

The aims of the study are to perform psychological intervention using EMDR Therapy (Eye Movement Desensitization and Reprocessing Therapy) in the preoperative period, evaluate the personality of each patient through the PFB test (Personality Factor Battery Test) at different times, compare the results obtained in the PFB test at different times of application and verify the existence of changes in the five major Personality Factors: Neuroticism, Extroversion, Socialization, Realization and Openness.

NCT ID: NCT03552367 Recruiting - Obesity Clinical Trials

Structured Exercise Prescription Program in Obese Children

Start date: December 1, 2017
Phase: N/A
Study type: Interventional

This controlled clinical trial aims to compare the effects of a multicomponent program that includes structured personalized exercise prescription in children with obesity with a control group that will be enrolled in a multicomponent program without structured personalized exercise prescription. All children will be followed for a period of 6 months. The parameters that will be evaluated between groups are physical fitness, anthropometry, metabolic (glucose oral tolerance curve, lipids, HOMA-IR, ISI-MATSUDA), early cardiovascular damage, inflammatory biomarkers, anxiety and depression scores, and allelic variants related to physical fitness.

NCT ID: NCT03545360 Recruiting - Obesity Clinical Trials

Safety and Efficacy of the BTL-703 Treatment for the Non-invasive Lipolysis

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

The study will evaluate safety and efficacy of the BTL-703 device for the non-invasive lipolysis.

NCT ID: NCT03538210 Recruiting - Bariatric Surgery Clinical Trials

Obesity Cohort Bichat Louis Mourier

COBILOM
Start date: February 16, 2018
Phase:
Study type: Observational

Obesity prevalence rapidly increased in the past decades in French population with multiple health consequences responsible for excess mortality. In the same period of time, the number of bariatric procedures have developed exponentially. Despite its great efficacy on weight loss but also on resolution of comorbidities, bariatric surgery is not without risks. Our hypothesis is that a better understanding of the physio-pathological consequences of obesity and bariatric surgery, notably on the gastrointestinal tract, may allow to improve the treatment of obesity and to find alternatives to bariatric surgery. The main objective of this cohort study is to systematize the collection and the conservation of biological samples (blood, stomach, liver, intestine, adipose tissue) obtained during bariatric surgery, in obese subjects undergoing surgery (including sleeve gastrectomy, Roux-en-Y gastric bypass, or revisional intervention for complication or weight regain) in the University Hospital group of Paris Nord Val de Seine (HYPNVS). The main projects that will build on this cohort will cover the physiopathology of obesity and its consequences, notably in the field of gastrointestinal tract including: modification of gastro-intestinal plasticity in severe obesity and after bariatric surgery and alterations of absorption of nutriments (lipids, proteins, carbohydrates) induced by obesity and bariatric surgery. The inclusion in this project of obese subjects before surgery, or lean or obese subjects after surgery will allow to distinguish the impact of weight loss and surgery on gastrointestinal remodeling. This cohort will also allow to characterize stomach and intestinal proteome in severe obesity and to precise the influence of tissue inflammation on metabolic disorders associated with obesity.

NCT ID: NCT03527420 Recruiting - Obesity Clinical Trials

DNA Methylation and Vascular Function

Start date: October 11, 2019
Phase: N/A
Study type: Interventional

The main objective is to examine DNA hypomethylation as an underlying mechanism for the increased production of inflammatory cytokines and the impaired vascular function in obese individuals and as a potential target for nonpharmacological preventive/therapeutic interventions such as aerobic exercise.

NCT ID: NCT03525002 Recruiting - Obesity Clinical Trials

Dopamine Action on Metabolism in Relation to Genotype

Start date: May 3, 2018
Phase: Phase 2
Study type: Interventional

Obesity is a widespread disease with increasing prevalence and associated with serious secondary complications. So far, the origin of the disease, regardless of an existing positive energy balance, is not fully understood. In addition to environmental factors, the genetic background plays an important role in the pathogenesis of obesity. Of common genetic polymorphisms, variants in the fat mass and obesity associated gene (FTO) locus have the highest effect size on body weight. Animal and first clinical studies indicate that FTO variants interact with dopamine signaling in the brain, thus influencing the risk of overweight. In fact, preliminary results indicate that enhancing dopamine signaling with the dopamine agonist bromocriptine, depending on the FTO genotype, either induces weight loss or has a neutral effect on body weight. The planned clinical trial serves to develop a genotype-specific and thus individualized therapy approach for obesity. The influence of dopamine agonist therapy on weight loss as a function of the FTO (rs8050136) genotype is to be tested. Here, the greatest weight loss is expected to occur in subjects carrying the homozygous risk-allele (AA). So far, there are only a few established conservative therapy forms of obesity, so that bariatric interventions with an increasing rate are necessary to achieve weight loss and thus a reduction in overall morbidity and mortality. Among the approved drug therapies for obesity, bromocriptine is commonly used. In addition, some interventions require injections. An early, conservative individualized, genotype-specific treatment with little side-effects would enable simple treatment of obesity. Study design: 150 obese (BMI > 30) subjects (50 / study center) will be enrolled in the study. The subjects will be stratified according to their FTO genotype (rs8050136). Subjects will be randomized into placebo or bromocriptine treatment group. Treatment will last for 18 weeks and a follow-up will be performed 30 weeks after baseline.

NCT ID: NCT03514602 Recruiting - Pregnancy Clinical Trials

Maternal Smoking Cessation and Pediatric Obesity Prevention

Start date: July 1, 2015
Phase: N/A
Study type: Interventional

The objective of this study is to test the effect of smoking cessation in pregnancy or in lactation on preventing rapid infant adiposity gain. Investigators propose a randomized, controlled experiment among smoking pregnant women from 1st prenatal care visit through 6 months of postpartum period. Two-phase randomization will be applied to separate the effects of smoking cessation in two different critical periods (i.e., pregnancy and lactation) on infant adiposity gain. Investigators will first randomly assign 40 smoking pregnant women into either the multicomponent intervention (N=30) or the education-only control group (N=10). The multicomponent intervention group will receive education and counseling, monitoring and feedback, contingent financial incentives, and family support, while the control group will receive education only. At the end of pregnancy, investigators will further randomize successful quitters (estimated N=20) from the multi-component intervention group into either the continuous multi-component intervention group in lactation (N=10) or the education-only control group (N=10). All women and their newborns will be followed from enrollment to 6 months postpartum. The key outcomes include maternal smoking abstinence confirmed by urine-cotinine and infant gain in weight-for-length z-score. Specific Aim 1 is to examine the effects of maternal smoking cessation intervention in pregnancy on infant gain in weight-for-length z-score from birth to 6 months. Specific Aim 2 is to examine the effect of maternal smoking abstinence intervention in lactation and infant post-weaning gain in weight-for-length z-score among the women who have successfully quit smoking in pregnancy.

NCT ID: NCT03509038 Recruiting - Obesity Clinical Trials

BUDI (Bariatric UroDynamic Improvement)

BUDI
Start date: March 13, 2018
Phase: N/A
Study type: Interventional

In the population of obese women, the prevalence of urinary incontinence (UI) is around 70%. It was shown in the literature that weight loss by bariatric surgery allowed a significant improvement in the symptoms and impact on the quality of life of the IU. However, no prognostic factor for recovery has yet been identified and the pathophysiological mechanisms underpinning this improvement are not fully elucidated. The main objective of this study is to highlight the urodynamic changes associated with the improvement of the symptom and quality of life scores in a population of incontinent obese women before and after bariatric surgery.

NCT ID: NCT03505658 Recruiting - Obesity Clinical Trials

Abriendo Caminos 2: Clearing the Path to Hispanic Health

Start date: April 10, 2015
Phase: N/A
Study type: Interventional

Obesity is significantly higher in specific ethnic groups and, in particular, Hispanics. There is an urgent need to implement culturally-sensitive lifestyle interventions and educational programs to decrease the burden of obesity and obesity-related metabolic diseases in Hispanic populations. Accordingly, our overreaching goal is to tailor an existing and successful community-based program, Abriendo Caminos, to leverage effectiveness in promoting healthy nutrition and life-style behaviors among low income, low literacy Hispanic-heritage families. Our multi-function integrated project proposes to (a) adapt Abriendo Caminos for 6-18 year-old children from Mexican and Puerto Rican heritage in five different locations (California, Illinois, Iowa, Puerto Rico, and Texas) and (b) Train existing professionals (in Extension and community agencies) and future professionals (Hispanic university students) to meet the specific needs of this population. Our central hypothesis is that participation in a 6-week community-based program will prevent childhood obesity/maintain healthy weight by significantly increasing: (a) healthy dietary behavior patterns and basic knowledge of nutrition; (b) physical activity levels; and (c) the organization of collective/shared family mealtimes. The implementation of this culturally sensitive, workshop-based curriculum in different regions across the country will help to train the next generation of professionals in Extension and communities to deliver programs that meet the needs of Hispanic families. The integration of Hispanic college students in program implementation via an experiential learning course will further strengthen the program, as well as increase recruitment and retention of Hispanic students, increasing the capacity of Hispanic communities to meet their own needs in the future.

NCT ID: NCT03490513 Recruiting - Obesity Clinical Trials

Aromatase Inhibitors and Weight Loss in Severely Obese Men With Hypogonadism

Start date: April 15, 2018
Phase: Phase 4
Study type: Interventional

The investigators have preliminary data suggesting that obese patients with hypogonadotropic hypogonadism (HHG) have minimal benefit from testosterone therapy likely because of its conversion to estradiol by the abundant aromatase enzyme in the adipocytes. The increased conversion of androgens into estrogens in obese men results in a negative feedback of high estradiol levels on hypothalamus and pituitary, inhibiting the production of gonadotropin-releasing hormone (GnRH), luteinizing hormone (LH) and follicle stimulating hormone (FSH) and, as a consequence, of testosterone by the testis. Testosterone administration could increase estradiol production, further promoting the inhibitory feedback to the hypothalamic-pituitary-gonadal axis. Although weight loss from lifestyle modification has been shown to reduce estradiol and increase testosterone levels, the effect is at best modest and weight regain results in recurrence of hypogonadism. The use of aromatase inhibitors, in combination with weight loss, could be an effective alternative strategy due to its action at the pathophysiology of the disease. Intervention Subjects (body mass index of ≥35, testosterone <300 ng/dl) will be randomized to the active (anastrozole) or control (placebo) group. Anastrozole 1 mg tablet / day will be self-administered with or without food, at around the same time every day (active group); placebo 1 tablet/day with or without food to take at around the same time every day (control group). The study duration will be 12 months. Both groups will undergo lifestyle intervention consisting of diet and supervised exercise program. Target weight loss will be at least 10% of baseline body weight during the intervention. Subjects will attend weekly group behavior modification sessions which will last ~75-90 min for the first 3 months and decreased to every two weeks from 3 to 12 months. Subjects will attend supervised research center-based exercise sessions during the first 6 months followed by community fitness center-based sessions during the next 6 months for at least 2 d/wk, with recording of home-based exercises for the other 2-4 days/week.