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Morbid Obesity clinical trials

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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: 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

NCT ID: NCT02381704 Completed - Morbid Obesity Clinical Trials

Cost Analysis of Bariatric Surgery in an Employee-based Healthcare System Following Surgery Coverage

Start date: April 2008
Phase: N/A
Study type: Observational

The overall purpose of the study is to determine prospectively the cost effectiveness of bariatric surgery following partial coverage by a large healthcare system.

NCT ID: NCT02374866 Completed - Obesity Clinical Trials

Monitoring Obese Patients : Impact on the Frequency of Monitoring Weight

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

The literature data show that long-term monitoring has an effect on weight loss, comorbidity and on improving the quality of life. However, there are still no studies on monitoring obese patients after taking initial multidisciplinary approach. The recommendations of the HAS 2011 advocated "continuous monitoring needed to prevent weight regain, monitor the consequences of overweight and treat comorbidities. This requires a long-term support. "The frequency of follow-up consultations is not specified and "must be adapted to achieve a weight loss target and maintain." Having no specific recommendations on the frequency of monitoring, the investigators chose to experiment closer monitoring than our current monitoring to assess what is the best frequency monitoring, in terms of: weight loss, quality of life, feeding behavior, changes in physical abilities, evolution of comorbidities associated with obesity. The recommendations of the HAS 2011 advocate support of a multidisciplinary obesity for weight loss of 5% to 10 %, which, if maintained, can reduce comorbidities associated with obesity (type 2 diabetes, hypertension, pain associated with osteoarthritis).

NCT ID: NCT02366624 Completed - Morbid Obesity Clinical Trials

Effect of Bariatric Surgery on Bile Acid Homeostasis

Start date: February 2013
Phase: Phase 3
Study type: Observational [Patient Registry]

The purpose of this study is to evaluate the effect of bariatric surgery in bile acid homeostasis and its interrelationship with the metabolic changes induced by the surgery. This study contemplates the following hypothesis: - Bariatric Surgery induce a new study state in bile acid homeostasis with higher bile acid synthesis in association with increased bile acid content. - The major effects of bariatric surgery on bile acid synthesis and is observed one month after surgery with a progressively decline during the first year of follow-up. - Gastric bypass increases serum bile acid content, postprandial plasma bile acid response and fecal bile acid excretion. - Serum bile acids changes induced by gastric bypass are positively correlated with changes in gastric inhibitory polypeptide (GIP) levels and postprandial concentration of insulin and glucagon like peptide-1 (GLP-1) and inversely correlated with thyrotropic hormone (TSH) and postprandial concentration of glucose. - Changes in postprandial plasma bile acid response induced by gastric bypass positively correlates with changes in postprandial concentration of insulin, GLP-1 and peptide YY (PYY) and inversely correlates postprandial response of ghrelin and glucose.

NCT ID: NCT02364128 Completed - Morbid Obesity Clinical Trials

Improving Patient Decisions About Bariatric Surgery

PCORI
Start date: January 1, 2014
Phase: Phase 2
Study type: Interventional

At least 15 million Americans are morbidly obese, or more than 100 pounds overweight. Medical treatments including drugs and behavior modification have proven ineffective in producing significant and lasting weight loss in this group. While bariatric surgery is extremely effective for most patients, it also carries risks for both short and long-term complications. There are currently four different types of bariatric surgery available and the risks and benefits of these procedures vary widely and are strongly affected by patient and clinical characteristics. Decision making under these circumstances should reflect informed patient's values and preferences regarding these trade-offs. Instead, the choice of bariatric procedure is more often driven by the beliefs and experiences of the bariatric surgeon that a patient happens to see. Variability in the type of surgery recommended to patients likely results from some combination of surgeons' subjective opinions and personal experiences with regard to the risks and benefits of the treatment options and delegated decision making on the part of patients. The goals of this research proposal are to develop, implement, and evaluate an informed decision support tool for treatment of morbid obesity. This project will be conducted within the context of the Michigan Bariatric Surgery Collaborative (MBSC), which is a statewide clinical registry and quality improvement program that has the participation of virtually every bariatric surgeon and program in the state of Michigan. The MBSC registry now includes externally audited clinical data for more than 80,000 consecutive bariatric surgery patients. MBSC outcome measures include complications occurring within 30 days as well as weight loss, comorbidity resolution, quality of life and satisfaction at 1, 2, and 3 years after bariatric surgery.

NCT ID: NCT02325141 Completed - Morbid Obesity Clinical Trials

Laparoscopic Sleeve Gasterectomy With or Without Pyloric Botulinum Neurotoxin Injection

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

Leakage is the most common complication after laparoscopic sleeve gastrectomy which may amount to 20% in some studies. We hypothesize that Clostridium botulinum neurotoxin A (BTX-A) injection into the pyloric sphincter during the operation may decrease the risk of postoperative gastric leakage.

NCT ID: NCT02323009 Terminated - Morbid Obesity Clinical Trials

Esophageal Balloon Guided Weaning of the Morbidly Obese Patient

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

This is a study to evaluate whether PEEP adjusted by use of an esophageal balloon to overcome negative transpulmonary pressure; or adjusted by use of "CStat" to achieve the best effective static compliance will have any effect on outcomes with respect to ventilator weaning in tracheotomized morbidly obese patients (BMI >=40) with at least one failed prior weaning attempt.