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Obesity, Morbid clinical trials

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NCT ID: NCT02124993 Completed - Severe Obesity Clinical Trials

The Effect of Sleeve Gastrectomy on Food Preference

FPQ
Start date: April 2013
Phase: N/A
Study type: Observational

This is a questionnaire asking about the sleeve gastrectomy surgery and how has it altered food preferences before and after surgery.

NCT ID: NCT02122029 Completed - Morbid Obesity Clinical Trials

Lifestyle vs.Surgery for Morbid Obesity Treatment

Start date: February 2003
Phase: Phase 3
Study type: Interventional

The purpose of the current study is to determine whether an intensive lifestyle intervention was as effective as surgery to treat morbid obesity nine years post-intervention.

NCT ID: NCT02121808 Completed - Morbid Obesity Clinical Trials

EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode

EPO2-PV
Start date: April 2014
Phase: N/A
Study type: Interventional

The risk of complications associated with airway management in obese patients is significant. The results of pre-oxygenation allow a prolonged non-hypoxic apnea time for the clinician. The increase in FRC and non-hypoxic apnea time is correlated. The best condition to accomplish the pre-oxygenation in morbidly obese patient is still undetermined in medical literature. This study is designed to evaluate the effect of different positions combined with different ventilation modes during the pre-oxygenation phase of anesthesia's induction. EPO2: PV will evaluate the effect of different combinations of positions and ventilation modes on pulmonary volumes (mainly functional residual capacity) in a morbidly obese volunteer.

NCT ID: NCT02118844 Recruiting - Morbid Obesity Clinical Trials

Laparoscopic Bariatric Surgery: Impact of Deep Neuromuscular Block on Surgical Conditions

BaChiBloPro1
Start date: July 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether deep neuromuscular blockade compared to moderate neuromuscular blockade may improve the surgical conditions in patients undergoing laparoscopic bariatric surgery.

NCT ID: NCT02113696 Completed - Morbid Obesity Clinical Trials

Intake of Omega 3 in Morbidly Obese Patients

Start date: May 2014
Phase: N/A
Study type: Interventional

Ingestion of capsules of omega 3 EPA and DHA, with 1.8 g of EPA and 1.2 g DHA for morbidly obese patients, will improve the inflammatory status? C-reactive protein? Weight?

NCT ID: NCT02101814 Active, not recruiting - Obesity Clinical Trials

Energy Balance and Inflammation in Obese Adults Bariatric Surgery Follow-up

Start date: March 2013
Phase: N/A
Study type: Interventional

The prevalence of obesity is steadily growing in many parts of the world in order to reach epidemic proportions. Changes in signaling pathways state of hunger and satiety contribute to the increase in obesity and metabolic syndrome. Currently, the white adipose tissue, also is considered a secretory tissue by producing numerous adipokines involved in a chronic state of inflammation, which may interfere with the neuroendocrine regulation of energy balance that affect the weight loss process. The bariatric surgery is recommended as the most effective tool in the treatment and control of morbid obesity. The study population will consist of patients undergoing bariatric surgery of type Roux-en-Y gastric bypass. The study was performed in Clinical Hospital of the Federal University of Paraná (UFPR). This is a prospective cohort study with follow up of 6 and 24 months. The aim of this study is to assess the effects of weight loss after bariatric surgery associated anthropometric characteristic, metabolic changes (glucose, cholesterol profile,hepatic enzymes, Fibroblast growth factor- 21(FGF-21), blood pressure), the profile of adipokines pro/anti-inflammatory (adiponectin, interleukin-6 (IL-6),interleukin-10 (IL-10), C reactive protein (CRP), plasminogen activator inhibitor-1 (PAI-1), tumor necrosis factor alpha (TNF-α), intercellular adhesion molecule-1 (ICAM-1), resistin, frizzled-related protein 5 (SFrp5) and neuroendocrine regulation of energy balance (leptin, neuropeptide Y (NPY) , alpha-melanocyte stimulating hormone (α-MSH), melanin-concentrating hormone (MCH) and agouti-related peptide (AgRP), as well as the quality of life in obese adults.

NCT ID: NCT02085369 Recruiting - Obesity, Morbid Clinical Trials

Effect of Bariatric Surgery on Cognition, Genetics and Lifestyle

Start date: January 2014
Phase:
Study type: Observational

Obesity bariatric surgery patients usually lose more than 50% of their former obesity within a relatively short time (~ 2 years). There is still a lack of knowledge about underlying psychological and biological mechanisms of decline in body weight. The intention of this project is to investigate whether bariatric surgery is associated with patients' cognitive ability, lifestyle and/or gene expression and metabolomics.

NCT ID: NCT02078934 Withdrawn - Weight Loss Clinical Trials

Endoscopic Gastric Plication for Weight Loss in Morbidly Obese Patients Prior to Incisional Hernia Repair

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

Incisional hernias occur in nearly 20% of all laparotomy incisions accounting for almost 400,000 ventral hernia repairs annually in the United States. There is an even higher incidence of incisional hernia recurrence after prior repair if the patient is obese. Each subsequent hernia repair leads to increased morbidity and durability. It is not infrequent that many surgeons will advise overweight or obese patients to lose substantial weight prior to complex incisional hernia repair. However, it is quite difficult for any individual to lose more than 8 pounds a month in a safe, rapid, and sustainable fashion. This is based on losing 2 lbs. per week utilizing diet and exercise alone. Many patients with incisional hernia are physically debilitated that they cannot engage in any substantial physical activity to lose weight. Traditional laparoscopic bariatric surgery (i.e. Roux-en-Y gastric bypass (RYGB) and SG), while feasible, is a technically challenging endeavor since prior abdominal surgeries increase the amount of intra-abdominal adhesions. Furthermore, there is still a subset of patients who are not candidates for laparoscopic weight loss surgery because of inability to tolerate pneumoperitoneum due to underlying physiologic dysfunction. - Novel minimally invasive endoscopic technique may help obese patients with an incisional hernia lose weight in a safe and rapid fashion. Early case reports and small case series on gastric bypass revision utilizing such endoscopic technique have shown promise in efficacious weight loss. There have been reports of achieving nearly 20-25% excess weight loss. Abu Dayyeh and colleagues have also demonstrated that endoscopic gastric plication as a primary weight loss procedure is feasible, but their reported follow-up was only 3 months.8 Brethauer, et al. from Cleveland Clinic performed transoral gastric volume reduction for weight management in 18 patients (TRIM TRIAL). They utilized the Restore Suturing System (Restore device) and reported a mean decrease in BMI of -4.0 ± 3.5 kg/m2. Mean excess weight loss was 27.7% ± 21.9% with no reports of adverse events.9 There have also been reports of not only weight loss but improved insulin sensitivity and secretion.10 Laparoscopic gastric greater curvature plication afforded a mean 50.7% excess weight loss at 12 months.11 The intent of this study is not to demonstrate endoscopic suturing to be a primary option for weight-loss surgery. Preliminary reports have shown such procedure is technically feasible but not durable and the effects of the procedure varied widely among the study participants.12 The investigators view this technology as a bridge for morbidly obese patients, who will need subsequent surgery for another surgical disease, to improve their body habitus and decrease their postoperative morbidity and mortality. The aims of the investigators study are: - Feasibility of endoscopic gastric sleeve plication - Define the technical aspects of endoscopic suturing for sleeve plication - Provide long-term follow-up for both weight loss and resolution of their co-morbidities - Time from the endoscopic procedure to their incisional hernia repair - Photographic evidence of the stomach after endoscopic plication during the incisional hernia repair There are several advantages for the proposed study. First it avoids entering the intra-abdominal cavity. Second, the procedure is performed solely with sutures obviating the need for stapling which may increase the risk of gastric leak from the staple line.13 Lastly, it avoids placing endoscopic intra-luminal devices such as intragastric balloons or duodenal-jejunal sleeves. Limiting factor of such devices is a high rate of premature device withdrawal due to intolerance. Furthermore, their effects are short-lived as most devices will need to be removed by 12 weeks and they only offer a mean 23.6% excess weight loss.13, 14 The implications of this study can be far-reaching. Once efficacy is demonstrated where enough weight loss is achieved that patients can safely and quickly undergo their incisional hernia surgery, the investigators can then conduct a retrospective case-control cross-matched study to further delineate its true benefit. If there is a true benefit, then a randomized control study can be employed in the future.

NCT ID: NCT02077517 Recruiting - Morbid Obesity Clinical Trials

Stapled vs Hand Sewn Anastomosis in Roux en Y Gastric Bypass for Morbid Obesity: Randomized Clinical Trial

STAVHAS
Start date: January 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study is to compare postoperative complications between hand sewn and stapled anastomosis after performing Roux en Y-Gastric Bypass as a treatment for morbid obesity.

NCT ID: NCT02076880 Recruiting - Type 2 Diabetes Clinical Trials

SLEEVEDIAB To Explore the Early and Late Metabolic Effects of Sleeve Gastrectomy in Obese Patients

SLEEVEDIAB
Start date: November 2013
Phase: N/A
Study type: Interventional

Sleeve gastrectomy is a restrictive procedure based on the removal of a large part of the gastric fundus. According to a recent randomized study, weight loss and resolution of diabetes are comparable to that obtained after gastric by-pass (79.7 % versus 80.3%), but with a lower morbidity. The mechanisms involved in the rapid resolution of diabetes after sleeve gastrectomy remain poorly understood, as no specific study in patients with type 2 diabetic obese are available. An increase in post- absorptive levels of Glucagon-like Peptide 1(GLP-1), Peptide YY(PYY) and insulin has been reported, but in non-diabetic subjects mostly. The important caloric restriction in the early postoperative period indeed improves hepatic insulin resistance, regardless of weight loss. Specific metabolic and hormonal effects of this surgical procedure cannot be excluded.The aim of our study is to explore the early and late metabolic effects of sleeve gastrectomy in severely obese patients with non-insulin-treated type 2 diabetes. We will also evaluate insulin sensitivity, insulin secretion and incretin effect. We will include 14 obese patients with type 2 diabetes, considered eligible to bariatric surgery according to HAS criteria, and whose diabetes treatment involves only metformin, sulfonylurea and glinides. They will be randomized to a 1-week caloric restriction period or no caloric restriction, immediately before surgery. Test meals with dosages of blood glucose, insulin, C-peptide, adiponectin, leptin, GLP-1, PYY and ghrelin will be performed before and after caloric restriction, and 1 week, 3 month, 6 month and 12 month after surgery.