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Obesity, Morbid clinical trials

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NCT ID: NCT02496611 Completed - Severe Obesity Clinical Trials

Enhancing Weight Loss Maintenance With GLP-1RA (BYDUREON™) in Adolescents With Severe Obesity

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

Long-term weight loss maintenance is seldom achieved by individuals with obesity owing to numerous biological adaptations involving appetite, satiety, and energy expenditure in the post- weight loss setting. Following a loss in body weight, peripheral and central mechanisms convey a sense that energy reserves have dwindled, activating a strong counter response to increase caloric intake. Adolescents with severe obesity are not immune to the vexing issue of weight regain. Indeed, only 2% are able to achieve and maintain clinically-meaningful weight loss with lifestyle modification therapy. Therefore, novel treatment paradigms focused on long-term weight loss maintenance are urgently needed. Pharmacotherapy has the potential to prevent weight regain by targeting specific counter-regulatory mechanisms in the post- weight loss setting. One of the most promising candidates is the glucagon like peptide-1 receptor agonist (GLP-1RA) class, which greatly enhanced weight loss maintenance following a short-term low calorie diet among adults with obesity. The rationale for focusing on GLP-1RA treatment (BYDUREON™) to prevent weight regain is supported by the multiple central and peripheral mechanisms of action targeted by this class of drug; many of which specifically address the biological adaptations known to induce relapse. The investigators have strong preliminary data demonstrating that GLP-1RA treatment reduces BMI in adolescents with severe obesity. Moreover, the investigators and others have shown that although meal replacement therapy (structured meals of known caloric content) can elicit robust short-term weight loss among adolescents with severe obesity, weight regain is a pervasive problem. Therefore, in this clinical trial, our innovative approach will utilize GLP-1RA treatment to target weight regain following short-term meal replacement therapy in youth with severe obesity. Participants who achieve ≥5% BMI reduction during the meal replacement phase will be randomized to GLP-1RA treatment or placebo for an additional 52 weeks while simultaneously engaging in lifestyle modification therapy. Importantly, this study will also allow us to examine the extent to which GLP-1RA treatment addresses mechanisms of weight regain, investigate other pleiotropic benefits of GLP-1RA, and identify predictors of weight loss response.

NCT ID: NCT02477956 Completed - Clinical trials for Vitamin D Deficiency

Effect of a Monthly High Dose of Vitamin D3 on Bariatric Surgery Patients

Start date: November 2012
Phase: Phase 1
Study type: Interventional

Bariatric surgery patients tend to have malabsorption of many micronutrients such as B12, Iron and vitamin D postoperative. So in this study, a monthly high dose of vitamin D3 is giving to patients with their routine supplements and followed up for 6 months. Hypothesis:Bariatric surgery subjects taking monthly high dose cholecalciferol supplements in addition to the standard vitamin D protocol will have a significant rise in serum vitamin D levels compared to the subjects taking only the usual vitamin D protocol.

NCT ID: NCT02476474 Withdrawn - Morbid Obesity Clinical Trials

GERD Following Laparoscopic Sleeve Gastrectomy

Start date: July 2023
Phase: N/A
Study type: Interventional

Laparoscopic Sleeve Gastrectomy (LSG) creates a vertical gastrectomy which results in a narrow and tubular shape of stomach. The line of resection starts at 3-6 cm. from pylorus (antrum) toward to the angle of His. The gastric antrum plays a major role in gastric emptying, particularly for solids. Hence, depending upon the starting point of gastric sleeve resection in each center, this can result in difference of the remaining gastric antrum which may affect gastric emptying time after this procedure.

NCT ID: NCT02475590 Active, not recruiting - Morbid Obesity Clinical Trials

Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass

Start date: March 2009
Phase: N/A
Study type: Interventional

Prospective randomized clinical trial aiming to compare laparoscopic Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) with primary outcome on excess weight loss, and secondary outcomes on nutritional status, glycolipid profile, quality of life and pain assessments.

NCT ID: NCT02466776 Completed - Cesarean Section Clinical Trials

Comparison of Staples Versus Subcuticular Suture in Class III Obese Women Undergoing Cesarean Delivery

Start date: June 2015
Phase: N/A
Study type: Interventional

The purpose of this study is to determine the optimal skin closure technique (staples versus subcuticular suture) at the time of cesarean delivery in Class III obese women with body mass index (BMI) of >/= 40kg/m2.

NCT ID: NCT02463435 Completed - Severe Obesity Clinical Trials

Effect of Nutritional Intervention and Olive Oil in Severe Obesity

Start date: June 2015
Phase: N/A
Study type: Interventional

Obesity is a worldwide epidemic with increasing prevalence, specially severe obesity (Body Mass Index (BMI) ≥ 35 kg/m2). It is a multifactorial disease that involves genetic and environmental factors that lead to increased mortality from cardiovascular disease, diabetes, cancer, among others and impairs life quality. Most research on severe obesity focuses on surgical alternatives and their results, thus this clinical trial aims to evaluate the effect of a non-pharmacological approach based on nutritional intervention and supplementation with a functional food, the olive oil. It will analyze the effectiveness of interventions on: weight loss, improvements on body composition and inflammatory profile (TNF-alfa, interleucins 1, 6 and 10, adiponectin), insulin resistance and serum lipids control, changing eating habits and physical activity practice, modification on bone mineral density and sarcopenia, and reduction of cardiovascular risk and other diseases. Also, it will be investigated the influence of polymorphisms (Pro12Ala of PPAR-γ gene, -174G>C of IL6 gene e Trp64Arg of ADRB3 gene) on nutritional intervention effectiveness with and without olive oil. This research looks for improving severely obese patient's care and contributing to effective results by reducing costs and risk treatment. The investigators believe that this informations will contribute significantly to the scientific field, expanding the knowledge about severe obesity.

NCT ID: NCT02431455 Recruiting - Pneumonia Clinical Trials

The Effect of Postoperative Incentive Spirometry on Pulmonary Function and Pulmonary Complications in Bariatric Surgery

Start date: June 2015
Phase: N/A
Study type: Interventional

This study evaluates the omission of incentive spirometry use following bariatric surgery. Half of participants will receive an incentive spirometer while the other half will not. Oxygen saturation and pulmonary complications after surgery will be measured to examine the effectiveness of incentive spirometry.

NCT ID: NCT02414893 Completed - Morbid Obesity Clinical Trials

Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients

Start date: September 2009
Phase: N/A
Study type: Observational [Patient Registry]

The mechanisms that regulate appetite in the morbidly obese are multifactorial and not well-known. Different peripheral signals (such as ghrelin or cholecystokinin) play an important role in the central regulation of appetite and hunger. Postprandial ghrelin and cholecystokinin (CCK) response has also an effect on gastric emptying that, in turn, has an effect on satiety sensation. On the other hand, bariatric surgery is supposed to affect hunger and satiety in and also promotes changes in gastric emptying which are not clearly defined. Aim: To better understand the physiologic mechanisms involved in the regulation of hunger and satiety in morbidly obese individuals, especially those related with gallbladder and gastric emptying, as well as those related with the response of the gastrointestinal hormones ghrelin, CCK and glucagon-like peptide-1 (GLP-1), before and after bariatric surgery (sleeve gastrectomy). Methodology: Three groups of individuals will be studied and compared: group A) non obese healthy subjects, group B) morbidly obese subjects and group C) morbidly obese subjects who had had a previous sleeve gastrectomy. In all subjects a standard meal test after a fasting night will be administered and appetite, satiety and hormonal response (ghrelin, CCK, GLP-1 and insulin) during 4 hours post-ingestion assessed, as well as postprandial gallbladder and gastric emptying by means of ultrasonography and the paracetamol absorption technique.

NCT ID: NCT02409160 Recruiting - Morbid Obesity Clinical Trials

Sleep and Immune Response in Severe Obese Patients Undergoing Bariatric Surgery.

Start date: March 2015
Phase: N/A
Study type: Interventional

Obesity is a major public health problem in developed and developing countries, causing a range of respiratory and metabolic changes. There is a strong correlation between obesity and cardiorespiratory sleep disorders. The weight loss reduces the comorbidities and improves the quality of life, but clinical treatment it is not effective for a long period. In this context, currently bariatric surgery is an option for the real weight loss in the long term. Obstructive sleep apnea (OSA) is a common clinical condition observed in patients with obesity. The primary aim of this protocol are to assess the inflammatory profile of severe obese patients undergone to bariatric surgery, through systemic and adipose markers of inflammation. A secondary objective is study the impact of this surgery on sleep variables and quality of life. Investigators hypothesized that weight loss induced by bariatric surgery reduces systemic inflammatory profile, improve sleep quality and quality of life of subjects with severe obesity. Will participate in this study, patients with severe obesity (BMI > 40 or 35 to 39.9 kg/m2 associated comorbidities), with indication of bariatric surgery, screened Bariatric Surgery Service of Santa Casa de São Paulo in São Paulo. Inclusion criteria are severely obese, bariatric surgery indication and agreement to participate in the study. Are excluded patients with BMI > 55 kg/m2, clinical instability, mental instability or significant and unrealistic expectations of surgery. Patients will be assessed before and after bariatric surgery, 90, 180 and 360 days. The evaluation protocol will consist of clinical history, vital signs, neck and waist circumference, clinical analysis of blood inflammatory markers, lung function tests, maximal ventilatory pressures, full overnight standard polysomnography, excessive daytime sleepiness scale, cardiovascular risk, quality of life and personal satisfaction questionnaires.

NCT ID: NCT02406976 Active, not recruiting - Morbid Obesity Clinical Trials

Effect Physical Exercise in Morbid Obesity

Start date: August 2010
Phase: N/A
Study type: Interventional

This objective study to verify the effect of physical training with and without behavioral cognitive therapy, compared with controls, in functional capacity and cardio-metabolic profile in individuals with morbidly obese