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Obesity, Morbid clinical trials

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NCT ID: NCT01431651 Recruiting - Morbid Obesity Clinical Trials

Probiotics Improve Gastrointestinal Symptoms After Roux-en-Y Gastric Bypass: A Prospective Randomized Trial

Start date: October 2011
Phase: N/A
Study type: Interventional

Obesity has been a global epidemic. Currently, bariatric surgery has been recognized as the only successful treatment for morbid obesity. Laparoscopic gastric bypass (LGB) is the leading bariatric surgery worldwide including Taiwan, it's resulted in significant weight loss and resolution of metabolic co-morbidities in morbidly obese patients . However, annoyed Gastro-Intestinal (GI) symptoms are a common complaint after gastric bypass like foul smell flatus, oil flatus and over flatus. The aim of this study was to determine whether probiotics would improve annoyed GI symptoms after gastric bypass. Probiotics are live microorganisms (in most cases, bacteria) that are similar to beneficial microorganisms found in the human gut. They are also called "friendly bacteria" or "good bacteria." Probiotics are available to consumers mainly in the form of dietary supplements and foods.

NCT ID: NCT01396460 Completed - Morbid Obesity Clinical Trials

Respiratory Quotient in Post Roux-en-Y Gastric Bypass Patients

RQ
Start date: May 2011
Phase: N/A
Study type: Observational

Through the values of respiratory quotient (RQ) it is possible to estimate the utilization of energy substrates by the body, or if there is a higher or lower fat oxidation. Experimental and clinical studies have shown that after Roux-en-Y Gastric Bypass (RYGBP) there is a decrease in the values of RQ, which may be associated with increased lipid oxidation in the postoperative period. Diet Induced Thermogenesis (DIT) is an important part of Total Energy Expenditure. We would like to know how it functions among RYGBP patients. The purpose of this study is to evaluate the RQ and DIT of patients in the post operative phase and compare the result with a control group consisting of morbid obese population.

NCT ID: NCT01394393 Recruiting - Obesity Clinical Trials

Virtual Environments For Supporting Obesity Treatment

AVATOB
Start date: January 2011
Phase: Phase 1
Study type: Interventional

Participants 60 Patients seeking treatment at the Obesity Unit of the Medica Sur Hospital in México City, Mexico. Informed consent to participate will be aleatory assigned to a three different conditions. Procedures In the initial interview, prospective participants will be provided with detailed information about the study and the treatments. All patients included in the study will be randomly assigned to the one (N=20) of the three treatment conditions described below, all conducted on an inpatient basis. The duration for all treatments will be 6 weeks and will be administered by two chartered clinical psychologists and one chartered psychotherapist under the supervision of a senior chartered psychotherapist. The three therapists will be balanced among the three conditions. 1. Nutritional groups In this condition (NT) the participants (N=20) subjects enter only 5 weekly nutritional groups held by dieticians based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum). 2. Cognitive-Behavioral therapy CBT group (N=20) will be based on the same treatment proposed in the first condition plus 15 additional sessions over 6 weeks. Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive—behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns. In particular, after the first week the patients will enter 5 weekly group sessions aimed at addressing weight and primary goals, and 10 biweekly individual sessions aimed at establishing and maintaining weight loss, addressing barriers to weight loss, increasing activity, addressing body image concerns and supporting weight maintenance. 3. Experiential Cognitive therapy Experiential CT group (N=4) involved the same treatment proposed in the first condition plus 15 additional sessions over 4/6 weeks. In the sessions we will use the "20/20/20 rule". During the first 20 minutes, the therapist focus on getting a clear understanding of the patient's current concerns, level of general functioning, and the experiences related to food. This part of the session tends to be characterized by patients doing most of the talking, although therapist guides with questions and reflection to get a sense of the patient's current status. The second 20 minutes is devoted to the virtual reality experience. During this part of the session the patient enters the virtual environment and faces a specific critical situation (Kitchen, Supermarket, Pub, Restaurant, Gymnasium, etc.). Here the patient is helped in developing specific strategies for avoiding and/or coping with it. In the final 20 minutes the therapist explores the patient's understanding of what happened in VR and the specific reactions - emotional and behavioral - to the different situations experienced. If needed, some new strategies for coping with the VR situations are presented and discussed. To support the empowerment process, the therapists follow the Socratic style: they use a series of questions, related to the contents of the virtual environment, to help clients synthesize information and reach conclusions on their own. In accordance with informed consent, assessments will be obtained before treatment, at posttreatment, 3 and 6 months after the treatment conclusion.

NCT ID: NCT01373892 Completed - Morbid Obesity Clinical Trials

Prospective, Randomised Study: Metabolic and Functional Effects of Bariatric Surgery Accessed Using PET and MRI.

Sleevepet2
Start date: January 2011
Phase: N/A
Study type: Interventional

The objectives of this study are to measure effect of obesity on brain structure and molecular pathways, food-stimuli mediated brain activation response, on hormones affecting both feeding and energy balance as well as on bone metabolism and bone marrow fat. In the first phase the studies are performed at baseline before bariatric surgery and in the second phase post-operatively after 6 months. Regional free fatty acid uptake are studied with PET and 14(R, S)-[18F]-fluoro-6-thia-heptadecanoic acid ([18F]FTHA). Changes in body fat distribution are investigated with magnetic resonance imaging (MRI) Brain reward system response to food stimuli is assessed using functional MRI (fMRI) and white and grey matter volumes using diffusion tensor imaging (DTI). Brain neurotransmitter system will be measured with [11C]raclopride and [11C]carfentanil and PET. In the second part of the study the same variables are studied after bariatric surgery: either laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass.

NCT ID: NCT01365416 Active, not recruiting - Diabetes Clinical Trials

Personalised Medicine for Morbid Obesity

Start date: December 9, 2011
Phase:
Study type: Observational

The prevalence of morbid obesity (BMI > 40 kg/m2) is increasing rapidly in the UK, but the investigators lack a coherent strategy for detailed assessment and treatment of the individuals affected, who are at high risk of morbidity and early mortality. The investigators already know that more than 1 in 20 severely-obese individuals have a simple genetic cause of their obesity (usually inherited in an autosomal dominant pattern. Bariatric surgery is the most effective treatment for morbid obesity and certain surgeries can result in the remission of type 2 diabetes. However, some patient fail to achieve the weight loss or experience complications and re-operations. The investigators are unable to predict the outcomes of bariatric surgery particularly in relation to type 2 diabetes remission which is crucial for the assessment of risk to benefit balance before wider future applications of the surgery. The investigators want to investigate the mechanism underlying Type 2 diabetes remission after bariatric surgery by A) examining the effect of Mendelian forms of obesity and diabetes on T2D remission, B) studying changes in expression profiling patterns in insulin-responsive tissues, C) identifying of eQTLs, and of other genetic variations affecting T2D remission and D) studying the role of epigenetic variation in T2D remission.

NCT ID: NCT01363193 Recruiting - Obesity Clinical Trials

Safety and Efficacy of Lean Body Weight-based IV Heparin Dosing in Obese/Morbidly Obese Patients

Start date: July 2011
Phase: N/A
Study type: Interventional

Standard weight-based IV heparin for normal weight patients is based on actual body weight (ABW). However, no well-defined guidelines have been established for patients considered to be obese or morbidly obese. In current practice, the calculated ABW based heparin initial bolus dose and infusion rates are quite high, and therefore often not used for obese/morbidly obese patients for fear of bleeding. Heparin is distributed in the body approximately the same as blood and does not get distributed to adipose tissue. There are some studies suggesting that lean body weight (LBW) might be a better basis for dosing heparin. LBW is a calculated weight that excludes the weight of fat. The investigators hypothesize that intravenous heparin dosing based on the Lean body weight of obese/morbidly obese patients would be safe and effective in achieving a therapeutic level of heparin in 24 hours compared to the usual practice in this patient population.

NCT ID: NCT01352403 Completed - Obesity Clinical Trials

Severe Obesity: Bariatric Surgery vs. Life-Style-Intervention

WAS
Start date: July 4, 2011
Phase: N/A
Study type: Interventional

The purpose of this study is to investigate the effects of weight loss induced by gastric bypass surgery in comparison to a psychotherapy-enhanced lifestyle intervention on cardiopulmonary performance and quality of life in patients with morbid obesity.

NCT ID: NCT01341028 Completed - Morbid Obesity Clinical Trials

Gut Hormones After Roux-en-Y Gastric Bypass (RYGBP) Plus Gastric Fundus Resection

Start date: May 2007
Phase: N/A
Study type: Interventional

- Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is considered a combination of restriction-malabsorption procedure and one of the most common operative procedures implemented. - Over the last years increasing evidence suggests that the beneficial effects of bariatric operations might be related to the suppression of appetite caused by the release of the anorectic gut hormones such as peptide-YY (PYY) and glucagon-like peptide-1 (GLP-1)by the L cells of the distal gut and the suppression of the orexigenic hormone ghrelin released by the stomach.Obese people have a blunted rise in PYY and GLP-1 after a meal, possibly resulting in impaired satiety and hence greater food intake. - In the present study the investigators sought to evaluate the effects of the resection of the gastric fundus, the main source of ghrelin production, on the secretion of ghrelin, PYY, GLP-1 and insulin and in addition on glucose levels, appetite and weight loss, in morbidly obese patients undergoing laparoscopic Roux-en-Y gastric bypass.

NCT ID: NCT01336725 Completed - Morbid Obesity Clinical Trials

Learning and Coping With Chronic Illness

Start date: January 2009
Phase: N/A
Study type: Observational

The purpose of this study is to determine whether the participants have improved their scores on health related quality of life (HRQL) 1 year after completing a learning and mastery course and whether sociodemographic variables are associated with HRQL.

NCT ID: NCT01330914 Completed - Obesity, Morbid Clinical Trials

Effects of Gastric Bypass Surgery and Calcium Metabolism and the Skeleton

Start date: July 2011
Phase:
Study type: Observational

Obesity is a chronic illness of staggering proportions. Because weight loss through diet and exercise is difficult to attain and maintain, there has been escalating interest in bariatric surgery, including Roux-en-Y gastric bypass. Gastric bypass surgery results in long-term weight loss, dramatic improvement in comorbidities such as diabetes, and decreased mortality. Emerging evidence suggests, however, that gastric bypass may have negative effects on bone health. Because of the serious consequences of osteoporosis and fracture, this is of great concern. This study of the effects of gastric bypass on calcium metabolism and the skeleton may positively impact the clinical care of gastric bypass patients by their surgeons, primary care providers, and endocrinologists. Further, the knowledge gained may inform future investigation into the relationships between obesity, weight loss, and bone biology.