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Obesity clinical trials

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NCT ID: NCT03015935 Recruiting - Obesity, Morbid Clinical Trials

Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery

Start date: January 2010
Phase: N/A
Study type: Observational

Laparoscopic surgery has become very popular and standard in many indications after advancements of technique. Various methods have been used in first entry to the abdomen. Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are important. Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced. There is no consensus yet on an optimal method has yet emerged. We aimed to evaluate efficacy of entry methods that ensures safe insertion of the first trocar at any site of the abdomen. To evaluate the efficacy of entry technique, we used cohort of patients who will be planned to laparoscopic obesity surgery. Two methods are commonly used in surgical literature and in our center. We have been used visible optical-entry technique in some patients for first entry and Veress technique in some other patients. For this purpose we designed an observational study.

NCT ID: NCT03015207 Not yet recruiting - Obesity Clinical Trials

First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of NNC0194-0499 in Male Subjects With Overweight or Obesity

Start date: January 2017
Phase: Phase 1
Study type: Interventional

This trial is conducted in The United States of America. The aim of this trial is to investigate Safety, Tolerability and Pharmacokinetics (the exposure of the trial drug in the body) of NNC0194-0499 in Male Subjects with Overweight or Obesity.

NCT ID: NCT03015012 Not yet recruiting - PreDiabetes Clinical Trials

Nutrigenomics, Overweight/Obesity and Weight Management Trial (NOW Trial)

Start date: February 2017
Phase: N/A
Study type: Interventional

We hypothesize that compared to the provision of population-based dietary advice, providing DNA-based dietary advice via personalized nutrigenomics testing (PNT) to 2 distinct patient populations (prediabetes patients and transplant recipients) will motivate them to adopt healthier dietary habits, lead to greater fat loss, increased percent lean mass and therefore improve health and quality of life outcomes for both patient populations. The second hypothesis is that dietary strategies related to the intake of one or more dietary components of interest will mitigate post-transplant weight gain associated with three SNPs of interest. This is a randomized clinical intervention trial involving a total of four groups of patients (n = 300). The two main patient groups include overweight or obese stable transplant recipients and overweight or obese patients who have been diagnosed with prediabetes. Within these two main groups, there will be two sub-groups. Patients in each of the two main groups will be randomized to receive either PNT or standard nutrition intervention (SNI). Baseline data will be conducted consisting of a 24-hour recall and 3-day food records using a validated multiple pass method (DiCecco et al. Nutr Clin Pract. 2014). Bioelectrical Impedance Analysis (BIA) will be conducted to assess body composition and to derive percent body fat and lean mass. Weight and height will be measured using a weigh scale and stadiometer. Those patients randomized to the PNT group will be instructed on a tailored nutrition care plan based on their individual nutrigenomics profile. At the same time, the SNI group will be instructed on general nutrition recommendations for weight loss using the standard tool ('Just the Basics') used by registered dietitians for transplant patients and prediabetes patients. Monthly email reminders will be sent to all participants as a reminder of their nutrition plan. 6-months after baseline data collection and individual nutrition interventions, baseline data will be repeated. After the study is complete, participants in the SNI group will be offered a nutrigenomics test and consultation with a registered dietitian. A paired t-test will be used to assess within group change from baseline to 6-month follow-up for: BMI, body fat, lean mass, and dietary intake. A repeated measures ANOVA will be used to test between group differences from baseline to 6-month follow-up for: BMI, body fat, lean mass, and dietary intake. If significant mean differences are detected, a Tukey's post hoc test will be used to compare differences by group. Statistical significance will be determined by P < 0.05. General linear regression models will be used to assess interactions between each genotype of interest and each dietary component of interest on BMI and body composition from baseline to 6-month follow-up.

NCT ID: NCT03014856 Completed - Obesity, Pediatric Clinical Trials

Metabolic Phenotypes in Childhood Obesity

Start date: May 2012
Phase: N/A
Study type: Observational

This study provides a sound basis towards a better understanding of the biochemical mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great importance towards the development of more personalized prevention and treatment in future.

NCT ID: NCT03014414 Not yet recruiting - Obesity Clinical Trials

Stanford Healthy Heart Study

Start date: January 2017
Phase: Phase 3
Study type: Interventional

People with elevated blood pressure are at higher risk of having a heart attack or stroke than people with lower blood pressure. Losing a modest amount of weight—such as 15 or 20 pounds—can reduce the risk of having a heart attack or stroke. However, it can often be a struggle to maintain weight loss over time. This study examines whether two behavioral weight-management programs can help people maintain weight loss over time. In this study, 346 adults will be randomly assigned (like flipping a coin) to one of the 12-month programs and followed for 36 months (i.e., 3 years) to see how their body weight may change.

NCT ID: NCT03013543 Not yet recruiting - Clinical trials for Bardet-Biedl Syndrome

Setmelanotide Phase 2 Treatment Trial in Patients With Rare Genetic Disorders of Obesity

Start date: January 2017
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of the study is to determine the effect of setmelanotide (RM-493) on weight, hunger assessments and other factors in patients with rare genetic disorders of obesity, including POMC deficiency, LepR deficiency, Bardet-Biedl syndrome and Alström syndrome.

NCT ID: NCT03012126 Enrolling by invitation - Clinical trials for Overweight and Obesity

Clinical & Community Approaches to Weight Management

Start date: December 2016
Phase: N/A
Study type: Interventional

This project seeks to build on innovative strategies to optimize the care of low-income children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement a new clinical-community intervention, theoretically grounded in the Integrated Clinical and Community Systems of Care Model, to address obesity through optimized screening and management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy Weight and Your Child weight management program (originally known as MEND). The study will examine outcomes for children that matter most to a broad group of stakeholders including parents, clinicians, and public health practitioners as well as inform the care of >7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.

NCT ID: NCT03012113 Recruiting - Obesity Clinical Trials

Mirabegron and Brown Adipose Tissue

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

Obesity and type 2 diabetes (T2D) are emerging problems worldwide. In particular South Asian individuals (representing 20% of the world population) have an increased risk of obesity and related disorders. They are at higher risk for the development of T2D as compared to white Caucasians and develop T2D at a younger age and with lower BMI. The underlying mechanisms that might explain these ethnical differences have not been clarified or understood yet. As a consequence, treatment options are limited and unfocussed, and novel specific strategies are needed. Brown adipose tissue (BAT) has recently been discovered as a major player in energy metabolism in humans. In a process known as thermogenesis, BAT takes up fatty acids (FA) and glucose from the circulation and subsequently combusts FA and glucose into heat, thereby increasing energy expenditure and improving glucose and FA metabolism. Using 18F-fluorodeoxyglucose (18F-FDG) (positron emission tomography/computed tomography) PET-CT scan analysis investigators have recently shown that South Asian individuals have less brown adipose tissue (BAT) than white Caucasians. This might suggest that they have a lower energy metabolism, which could underlie their increased predisposition for obesity and the development of T2D. Activation of BAT, for example by cold exposure, was shown to have beneficial metabolic effects in humans. Cold acclimatization can increase BAT volume, nonshivering thermogenesis, glucose uptake by BAT, as well as decrease fat mass in healthy young men. Therefore activation of BAT is considered as a novel therapeutic target in the treatment of obesity and T2D. As cold exposure is not the most desired therapeutic strategy for humans, current pre-clinical research focuses on pharmacological activation of BAT. β3-receptor agonists can be used to mimic sympathetic innervation of BAT. Our recent studies using mice with a human-like lipoprotein profile showed that treatment with a β3-receptor agonist decreased fat mass, improved dyslipidemia, increased insulin sensitivity and even attenuated the development of atherosclerosis. Likewise, the novel β3-receptor agonist (Mirabegron) has recently been shown to activate BAT in healthy young men as effectively as cold exposure. Therefore, ß3-receptor agonism would be a promising treatment option to activate BAT and enhance energy expenditure, especially for South Asians. Currently the most common way to visualize BAT in humans is by 18F-FDG PET-CT scan. However this method is both expensive and invasive, as it uses ionizing radiation. Recently, MRI, which has no radiation burden, has emerged as a novel method to visualize BAT in humans. Activation of BAT results in combustion of intracellular lipid stores, which eventually leads to a lower triglyceride (TG) content. MRI can measure TG content of tissue, and using MRI technology the activation of BAT can be quantified by the relative reduction in the TG content of BAT. The use of MRI to visualize and quantify BAT activity is a safe, cost-effective and innovative alternative to PET-CT, which has a potential to become a new gold standard in the nearby future. To investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic phenotype of South Asians, investigators will perform a randomized cross-over study in which 20 healthy young men aged 18-30 years with a lean body type (BMI <25 kg/m2) are included. Dutch South Asian individuals (n=10) and matched Dutch white Caucasian individuals (n=10) will participate in a cross-over study consisting of three different regimes. This study will investigate whether β3-receptor agonism has therapeutic potential to improve the metabolic phenotype of South Asians. The effects of a β3-receptor agonist on BAT activity in South Asians have never been studied before. Elucidating the effects of this β3-receptor agonist on BAT activity in South Asians might have major clinical implications, as it might result in the discovery of a potential novel treatment strategy to combat obesity and T2D in this especially vulnerable population.

NCT ID: NCT03009825 Not yet recruiting - Obesity Clinical Trials

TrOma: A Study Investigating Trauma Exposure, Emotion Regulation and Eating Pathology in Obese Patients

Start date: January 2017
Phase: N/A
Study type: Observational

The purpose of this study is to investigate the associations between lifetime exposure to traumatic events, emotion regulation strategies, and eating pathology of patients with obesity.

NCT ID: NCT03009695 Recruiting - Obesity Clinical Trials

Transcranial Magnetic Stimulation (TMS) in Obesity

Start date: February 2015
Phase: Phase 2
Study type: Interventional

Obesity is a metabolic disease that has reached epidemic proportions. Insofar no long-term effective drug treatment was developed for obesity. Lyfe style modulation and bariatric surgery are the only interventions with a limited rate of success. Obesity is due to several factors, mainly linked to a neurophysiological mechanism of "food addiction". We propose the use of repetitive deep Transcranial Magnetic Stimulation (dTMS) to reduce appetite and food craving in obese subjects, leading eventually to a weight reduction. dTMS was already tested successfully in other forms of addiction (smoking, alcohol, cocaine) and we hypothesized that it could be useful in the treatment of food addiction, and therefore in obesity. End-points of this research will be: 1) effect on food craving; 2) acute and chronic effects on blood level of hormones acting on the appetite regulation; 3) chronic effects on body weight. The demonstration that a safe, non-invasive and repeatable methodology can treat obesity reducing food craving and modulating appetite/satiety hormones secretion will constitute a cornerstone in translational medicine of metabolic diseases.