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Obesity clinical trials

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NCT ID: NCT03675035 Completed - Obesity Clinical Trials

Endomina Post RYGB

Start date: October 13, 2017
Phase: N/A
Study type: Interventional

Surgery is the only effective treatment for morbid obesity and can be divided into restrictive surgeries (Lap Band and Sleeve gastrectomy), malabsorptive surgeries (Biliary pancreatic deviation and duodenal switch) or a combination of both (RYGBP). This later technique is the most common and most effective surgical procedure performed worldwide and has been processed to be an effective treatment of morbid obesity and its complications, achieving excess weight loss of 65 to 80 % ; 1-2 years after surgery.1 However, after the initial weight loss induced by RYGBP; 50 % of patients regain some weight 2 and approximately 20 % of the patients will reach again a BMI of 35 at 10 years , defined as a failure rate.3 The reasons for weight regain are multiple but the most two potential contributing factors are related with the loss of the restrictive effect of the RYGBP by stretching of the gastric pouch and/or the gastrojejunal anastomosis (GJA), leading to increased satiety. Surgical options available for treating weight regain after RYGBP include placement of adjustable gastric band, Redo of the anastomosis or Reconstruction of the pouch.4 These procedures are technically difficult especially in patients who had previous single or multiple surgical interventions leading to a morbidity of around 15 % and a mortality of 1 %; Which is twice the one of the original surgery. This justifies the interest in less invasive, peroral revisions that include injection of sclerosant or suturing the anastomosis using Endoluminal gastroplication device (EndoCinch; Bard) 5,6 They have been however of marginal effectiveness compared to the medical treatment may be because their effect is limited to the anastomosis and doesn't reduce the size of the stretched gastric pouch. StomaphyX (Endogastric Solutions, Redmond, WA) is another systems aiming to reduce the gastric pouch has proved initial efficacy but are disappointing on the long term by a lack of persistence of the plicators. 7, 8 Endomina (Endo Tools Therapeutics, Nivelles, Belgium) is CE mark robot driven device that may be attached to an endoscope inside the body and allows remote manipulation of the arms of devices during a peroral intervention. It offers the possibilities of making transoral surgical full thickness sutures and may allow performing, via a transoral route, an intervention combining anastomoses reduction and gastric pouch reduction. It might be an effective treatment option for patients regaining weight after RYGBP and having a stretched pouch and or anastomosis.

NCT ID: NCT03673813 Completed - Clinical trials for Hypothalamic Obesity

A Personalized Program of Physical Activity and Diet for Hypothalamic Obesity

OH_APADIET
Start date: June 29, 2016
Phase:
Study type: Observational

Hypothalamic obesity (HO) is an obesity secondary to an alteration of the functioning of the hypothalamus, the central organ of energy homeostasis. The causes of OH are related to an hypothalamic lesion (eg craniopharyngioma) or to genetic diseases (ex: Prader-Willi syndrome). OH, which accounts for about 5 to 10% of obesity, is a complex handicap characterized by severe obesity associated with eating disorders, cognitive and behavioral disorders and sometimes a visual deficit, with a major impact on quality of life, morbidity and mortality. There is currently no specific treatment of HO. Management is essentially behavioral, based on daily support of eating behavior and physical activities (PA). OH is characterized by an intense and almost permanent hunger felt, a satiety disorder and an obsessive interest in food. The food education of the entourage is essential, the advise concern the control of the access to food and the setting up of a precise food frame on the quantities, with low energetic density, and schedules. OH is characterized by obesity with lean mass deficit. PA must therefore be regular, adapted to the disability and personalized to take into account cognitive deficits and behavioral disorders. Although the supervision of meals and daily PA is now recognized as fundamental in the care of these patients (National Program of Diagnosis and Care established by the French "Haute Autorité de Santé"), few studies have evaluated the effectiveness of programs with personalized support on global health. The investigators hypothesize that a personalized 4-month individual home-based counseling program on dietary counseling and PA can be effective to modify behaviors such as diet and PAs with an impact on changing weight and quality of life. The 16-week program includes a dietetic component (initial assessment with dietary care plan followed by a 30-minute telephone interview every month with dietician) and a PA component (two 1-hour individualized sessions, performed at home and supervised by a PA educator). Before and after the program, the investigators will evaluate habitual PA with an accelerometer, feeding behavior, physical functioning, weight change, body composition, quality of life and will constitute a biobank of serums, adipose tissues and stools. If the effectiveness of this program is demonstrated this will help to find ways to sustain this support by the institutions, to train professionals in the complex accompaniment of these patients. Finally this program set up as part of a rare disease can show the benefits in other populations of more common pathology (common severe obesity, intellectual disability, behavioral disorders).

NCT ID: NCT03673111 Completed - Obesity Clinical Trials

Study of the Gut Hormone Analogue Y14 in Adult Subjects

Start date: May 10, 2017
Phase: Phase 1
Study type: Interventional

A randomised, placebo controlled Phase I study to investigate investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects.

NCT ID: NCT03672903 Completed - Obesity Clinical Trials

Effect of Different Weight Vests on Body Weight in Obese Individuals

EVO
Start date: September 27, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

Obesity related ailments, such as cardiovascular diseases (CVD) and metabolic disorders are major causes of death in the Western World. The proposed research may result in improved prevention, diagnosis and treatments of obesity and obesity-related disorders. Recently published data show that if a weight is carried by a rodent, this animal will lose body weight and gain an improved glucose control. We aim to confirm these findings in a human model. We plan to let obese subjects carry weight vests and monitor their change in body weight. We will also measure appetite, physical activity and insulin sensitivity to further examine the potential beneficial effects of loading. Blood sampling will be performed to investigate the mechanism of action.

NCT ID: NCT03672227 Completed - Childhood Obesity Clinical Trials

Obesity Prevention in Head Start

Start date: August 24, 2018
Phase: N/A
Study type: Interventional

Family style dining is a widely-advocated approach by which to feed children in early education settings. While family-style dining is hypothesized to allow children to attend to their hunger and satiety and consume only the amount of food they need to meet their energy needs, children's ability to self-regulate eating in this setting is dependent on a number of factors including early life experiences, the feeding strategies caregivers use during meals, and the eating environment. The goal of this study is to develop and implement a novel curriculum for childcare providers, Mealtime Matters, that addresses the factors that interfere with children's self-regulation of eating and offers caregivers strategies to reduce exposures that promote over-eating in the early education environment. Mealtime Matters will be pilot tested through a randomized controlled trial design with 7 Head Start classrooms, enrolling approximately 72 low-income preschool-aged children. Intervention feasibility and acceptability will be examined, as well as changes in caregiver/child mealtime interactions and children's dietary intake during meals at Head Start. Study results will inform the development of a fully-scaled efficacy trial.

NCT ID: NCT03670875 Completed - Clinical trials for Obesity in Childhood

Non-Pharmacologic Alternatives for Childhood Obesity

Start date: July 31, 2021
Phase: N/A
Study type: Interventional

Childhood obesity is a global health issue. Mexico has been considered as the country with the higher number of children with obesity. There are not approved drugs to support diet and exercise as the first step to lose weight. Animal models and clinical trials in adults have provided evidence about safety and efficacy of interventions such as: prebiotics, curcumin, and omega- 3 fatty acids. The hypothesis of this study is: that non-pharmacological alternatives could support diet and exercise to decrease the weight of children with obesity.

NCT ID: NCT03667469 Completed - Obesity Clinical Trials

Study of the Life Expectancy of Patients With Metabolic Syndrome After Weight Loss:

LIFEXPE-RT
Start date: May 24, 2018
Phase: N/A
Study type: Interventional

Background and study aims: Surgical and non-surgical normalization of body weight with obesity leads to a significant improvement in health and regression of metabolic syndrome. But as the reduction in body weight with obesity changes the life expectancy remains not clear enough. The use of endoscopic staplers does not exclude the emergence of serious complications of surgery, for example, including bleeding and leakage in the stapler suture line. Therefore, the advantages of using a band in the bariatrics are justified from a security standpoint. Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). The proposal to use for the staple-free (stepleless or steplerless) creation of a pouch (band-separated gastric bypass) with use for band a vascular prosthesis is justified, but it requires comparison of this method with a stapler variant. An important issue is comparing surgical and non-surgical weight loss with obesity and metabolic syndrome and comparing life expectancy with confirmation of changes in telomere length. This study compares loss of weight, changes in other health conditions that the patient may have (co-morbidities, such as diabetes), telomere length, quality of life, the number of complications and side effects, the degree of complexity of the surgical technique and operating costs of a new laparoscopic band-separated mini- gastric bypass (LBSMGB) procedure compared with the standard stapler (linear cutter) - separated mini-gastric bypass (LSSMGB). Additionally, surgical treatment will be compared with non-surgical treatment (hypocaloric diet therapy). Who can participate? Obese adult patients with a BMI of between 30 kg/m2 and 50 kg/m2. What does the study involve? Participants are randomly allocated to one of three groups. Those in the first (A) group undergo the laparoscopic band-separated mini-gastric bypass procedure. Those in the second (B) group undergo the linear cutter stapler-separated mini-gastric bypass procedure. In three (C) group including standard lifestyle intervention on weight and hypocaloric diet therapy. All patients are then followed up one month after surgery and again after 6 and, finally, 12 months after surgery where the changing body mass index, changes in co-morbidities, change telomere length and quality of life are assessed.

NCT ID: NCT03666156 Completed - Obesity Clinical Trials

Adult Weight, Genetics and Lifestyle Factors

Start date: September 1, 2018
Phase:
Study type: Observational

Childhood obesity leads to adulthood obesity, demonstrated in many retrospective and longitudinal studies. Genetics as a predictor of obesity is less established. Morandi et al, (2012) assessed whether lifestyle and genetic factors can be used to predict childhood obesity, concluding that genetics had minimal predictive effect. More recently Seyednasrollah, (2017) demonstrated that genetic information, when alongside clinical factors for cardiovascular disease, increased the predictive accuracy of obesity risk in adults. This study aims to investigate if known lifestyle and genetic risk factors are associated with BMI and if they can be used as predictors of overweight/obesity in adults.

NCT ID: NCT03665961 Completed - Central Obesity Clinical Trials

The Association Between Microbiota, Endotoxaemia and the Host Obesity/ Insulin Resistance (MiPOOP Study)

MiPOOP
Start date: October 25, 2016
Phase:
Study type: Observational

The objectives of this study are to examine the effects of ethnicity, central obesity and dietary components, on the human gut microbiome. The investigators hypothesize that these factors have an influence on the composition of the gut microbiome. Healthy subjects (n=35) provided stool samples for gut microbiome profiling using 16S rRNA sequencing and completed a dietary questionnaire. The serum samples were assayed for a panel of inflammatory cytokines. Their associations with central obesity were examined.

NCT ID: NCT03665857 Completed - Pediatric Obesity Clinical Trials

Childhood Obesity Intervention Study

Start date: September 11, 2018
Phase: N/A
Study type: Interventional

Globally, childhood overweight and obesity is a public health problem. Although the rising trend in children's body mass index (BMI) has plateaued in some high-income countries, it has accelerated in low- and middle-income countries. It is especially true amongst Chinese children with the annual increase rate of obesity during 2010-2014 greater than any other periods from 1985 to 2010. With the dramatic economic development in China, children are now growing up in an increasingly 'obesogenic' environment. For example, the availability and ubiquity of computers and smart phones promote sedentary time, and access to energy dense food and sugar sweetened beverages is now widespread. Effective childhood obesity intervention is urgently needed in China. Although over 20 intervention studies for overweight/obesity among children and adolescents have been conducted in China since the 1990s, most of them had moderate or serious methodological weaknesses. For example, they did not report the number of students, schools or districts initially approached to participate, raising the possibility of selection and recruitment bias. Additionally, although they stated the allocation of intervention and control were randomized, no description of the method of randomization was reported. Given the relative lack of high-quality interventions for childhood overweight/obesity, the investigators designed a cluster randomized controlled trial to assess the effectiveness of a multicomponent one-academic-year intervention among 24 primary schools (approximately 1200 students) in the eastern (Beijing), middle (Shanxi) and western (Xinjiang) part of China. The study aims to identify: 1) whether the school-based intervention will be effective for preventing excessive weight gain among children; 2) whether the intervention will be beneficial for improving healthy eating, physical activity and reducing sedentary behaviors among children.