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The purpose of the registry was to observe the safety and effectiveness outcomes for subjects treated with the EndoBarrier in the post market setting where the product had Conformité Européene (CE mark) regulatory approval and in accordance to the approved Indication For Use.
The study will take place at a cafe managed by university dining services and is located in a university building adjacent to the psychology building. The cafe sells sugar-sweetened beverages and a variety of diet drinks. The campus dining services and the manager of the cafe have given investigators permission to "tax" their sugar sweetened beverages and will provide their sales data for a 12 week period. The investigators will introduce four arms to the experiment. One arm will be baseline data where business 'as usual' will be conducted and no price increases will be implemented on SSBs. In the general tax condition the investigators will introduce a 3 cent/ounce tax on the five SSB flavors the café offers. In the Pre-K tax condition the investigators will institute a 3 cent/ounce tax but will label the tax as proceeds going to Pre-K education. This is designed after the Philadelphia tax that was recently passed where funds were earmarked to benefit childhood education. In the childhood healthy eating program condition the investigators will institute a 3 cent/ounce tax but will label the tax as proceeds going toward childhood healthy eating programs. In all tax conditions the firm will keep the proceeds, but the research team will make a donation to a Pre-K education non-profit and a childhood healthy eating non-profit of the amount generated by the tax during the study period. Each experimental arm will run for 3 weeks total (for a total study period of 12 weeks). The conditions will alternate by week (i.e., week 1: business as usual; week 2: general tax; week 3: pre-K tax; week 4: childhood healthy eating tax; week 5: business as usual, etc). A research assistant will visit the café each week to make any necessary changes to signs that will label the drinks. The investigators will change the signage of the drinks in the cooler during the study period. For the baseline period there will be no changes to the signs made. Currently all beverages are labeled with their name and cost (e.g., Pepsi, $1.89). In the tax conditions the investigators will change the price of the drink (3 cents/ounce) and add a line notifying consumers of the soda 'surcharge' (note "surcharge" will be used in the study because no tax was actually passed by the local government). An example of this sign would be 'Pepsi, $2.29, includes 40 cent sugary drink surcharge.' In the Pre-K tax condition an added line will say, "Pepsi, $2.29, includes a 40 cent sugar sweetened beverage surcharge. Proceeds benefit Pre-K education." In the childhood healthy eating programs condition the text will say, "Pepsi, $2.29, includes a 40 cent sugary drink surcharge. Proceeds benefit Childhood Healthy Eating programs."
The primary objective of this study is to evaluate the Carboxipeptidase D (CPD) genotyping as a predictive biomarker of body weight and/or fat mass reduction in obese patients treated with perindopril. There is nonclinical and clinical evidence that a subgroup of human subjects may present a decrease in body weight and/or fat mass following treatment with perindopril. Although the individual characteristics that determine such effect are still unknown, Gene PreDiT SA (Biocant Park, Cantanhede, Portugal) discovered that certain genetic characteristics (e.g., single nucleotide polymorphisms (SNPs) of CPD gene) may play a role and potentially could serve as a potential predictive biomarker of response to perindopril. These promising results, along with the fact that perindopril is a medicine already in use in clinical practice, led Gene PreDiT SA to decide to proceed with the development of a theranostic approach for the treatment of obesity. Such theranostic approach consists on the use of CPD genotyping to identify obese subjects that could present improved body weight and fat mass reduction following treatment with perindopril. The current clinical trial aims to prove the concept and provide data to design further confirmatory studies. Additionally this study will evaluate the association between CPD SNPs genotypes and response to perindopril; the effect of perindopril in waist circumference, waist/hip ratio, and BMI and the tolerability and safety of perindopril in the study population.
The purpose of this study is to evaluate the LINX device in patients who have previously undergone laparoscopic sleeve gastrectomy (LSG) for obesity and have chronic gastroesophageal reflux disease (GERD). The study will monitor safety and changes in reflux symptoms.
This study will determine the effects of supplementing beta-hydroxy-beta-methylbutyrate (HMB) on body composition and strength changes during weight loss. When overweight and obese persons lose weight, and in particular in conjunction with dietary restrictions, muscle, bone mass, and muscle strength are also lost. HMB has been shown to preserve muscle mass and strength, and it is thought that HMB may also preserve muscle, bone, and strength during weight-loss.
The loop duodenal switch (L-DS) is a single-anastomosis biliopancreatic diversion with duodenal switch (BPD-DS) procedure. The original BPD-DS has two-anastomosis and is an accepted and approved bariatric procedure by the American Society of Metabolic and Bariatric Surgery. Preliminary data from Sanchez-Pernaute et al. (2013) indicates that the L-DS procedure is safer and easier to perform as it only requires one anastomosis compared to the BPD-DS, and offers good results for treatment of both morbid obesity and its metabolic comorbidities, including type-2 diabetes mellitus. However, the initial publications of the loop DS still resulted in a small number of patients with total protein malnutrition. For this reason, the investigators will study the loop DS with a modification of the originally published technique with a longer common channel limb (300 cm) to reduce the risk of protein malnutrition For patients with a BMI >50, many are limited to just a sleeve gastrectomy as other bariatric procedures are technically challenging with increased operative risk. A loop duodenal switch may be a safer operation with improved weight loss for the super-morbidly obese patient.
This study tests the feasibility of a health and wellness trial designed with community input. This 12-week program will be tested over a 24-week period using a delayed treatment control group.
The purpose of this study is to evaluate cardiovascular (CV) safety of naltrexone hydrochloride (HCl) and bupropion HCl extended release combination (NB) compared with placebo and rule out excess risk of major adverse cardiovascular events (MACE) when given in combination with standard of care in overweight and obese participants with documented history of CV disease.
This study will evaluate the safety and efficacy of the EndoBarrier® SANS™ in overweight and obese subjects with type 2 diabetes. The barbless second generation device is being developed as a means to reduce the incidence of adverse events associated with the barbs of the predicate device while maintaining a similar efficacy profile as measured by changes in weight and diabetic endpoints (HbA1c, blood glucose, insulin, etc.). This first use in human will primarily evaluate preliminary safety, tolerability and efficacy of the new design. Because of the new design and its first study in human subjects, only a 3 month implant duration will be evaluated in this study.
Vitamin D insufficiency is an increasing trend in the United States. According to the NHANES data collection there was a near doubling of patients with vitamin D deficiency in 10 years. Vitamin D deficiency is associated with several adverse outcomes such as increased fractures, certain microbial diseases, cardiovascular diseases, and metabolic dysfunction. The increasing prevalence of vitamin D deficiency has been attributed to the increasing prevalence of obesity. Several studies have shown that obese patients have lower 25-OH vitamin D (25-OHD) levels compared to nonobese patients and obese patients require more vitamin D compared to nonobese patients. The most commonly prescribed medication to replete vitamin D deficiency is oral ergocalciferol. To date, no prospective trials have been published to evaluate a standard protocol in the treatment of vitamin D insufficiency in adults.