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Obesity, Morbid clinical trials

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NCT ID: NCT00434525 Completed - Morbid Obesity Clinical Trials

Laparoscopic Sleeve Gastrectomy With and Without Omentectomy

Start date: January 2008
Phase: Phase 3
Study type: Interventional

- The investigators aim to determine the clinical and metabolic effects of sleeve gastrectomy with or without omentectomy in the treatment of morbid obesity. - The investigators hypothesize that the endocrine suppression of ghrelin (appetite hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits for morbidly obese patients.

NCT ID: NCT00433810 Completed - Morbid Obesity Clinical Trials

Longitudinal Assessment of Bariatric Surgery

LABS-1
Start date: March 2005
Phase: N/A
Study type: Observational

The goal of the LABS-1 study is to assess the short-term safety of bariatric surgery.

NCT ID: NCT00431587 Recruiting - Metabolic Syndrome Clinical Trials

Changes in Different Fat Compartments and Their Effect on Particular Manifestations of Metabolic Syndrome After Bariatric Procedures.

Start date: June 2007
Phase: N/A
Study type: Observational

The metabolic risks associated with obesity are closely correlated with central (abdominal), rather than a peripheral (gluteofemoral) fat pattern It has been shown that weight loss after bariatric surgery is followed by metabolic improvements. The amount of fat lost from each site may be independently regulated. Very scant information is found in the literature regarding the relative changes in different fat body compartments, and their effect on the improvement of the metabolic profile. In this study we define the absolute and relative changes in the different adipose tissue compartment after weight loss surgery

NCT ID: NCT00395681 Completed - Morbid Obesity Clinical Trials

Population PK/PD of Propofol in the Morbidly Obese Patient

Start date: September 2007
Phase: Phase 4
Study type: Interventional

Rationale: The extreme increase of obesity in the last years had led to this study. There is no consensus about how to anaesthetise morbidly obese patients. The amounts of narcotics given vary widely and rather depend on the anaesthetist than on the pharmacokinetics and dynamics in the morbidly obese patient. Reason for this is that it is not clear in what extend the pharmacokinetics and dynamics are affected in the morbidly obese patient. Objective: The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40). A covariate analysis will be performed in order to account for variability in pharmacokinetic and/or pharmacodynamic parameters. This model will take into account patient and procedure bound covariates. The results will be used to develop individualised dosing schemes of Propofol when used for induction and maintenance of anaesthesia in morbidly obese patients. Study design: A randomised, therapeutic and non-invasive study. Study population: Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic banding or gastric bypass surgery, 18-60 year old. Intervention (if applicable): Patients will be randomised into two groups, one group will be given 200 milligrams of Propofol and the other group will be given 350 milligrams of Propofol. During the induction of anaesthesia with Propofol over 60 seconds, the patient is asked to count in order to measure time to induction of anaesthesia. During and following anaesthesia a maximum of 50 ml of blood will be taken from an indwelling arterial line. Depth of sedation will be measured using non-invasive Bispectral Index (target 40-60) and other standard measures (heart frequency and blood pressure). Main study parameters/endpoints: Primary endpoints: pharmacokinetic parameters; clearance, intercompartmental clearance, volume of central compartment and volume of peripheral compartment. Secondary endpoints: pharmacodynamic parameters; time to induction of anaesthesia (stop counting, eyelash reflex, quality of anaesthesia, corresponding dose required for induction of anaesthesia for both induction doses), EC50 using BIS, required doses of Propofol during maintenance of anaesthesia, wake-up time. Nature and extent of the burden and risks associated with participation benefit and group relatedness: A maximum amount of 50 milliliters of blood will be sampled from an indwelling arterial line. The patient will be asked to count slowly during induction of anaesthesia. Both induction doses of 200 and 350 milligrams are currently used standard induction doses for morbidly obese patients.

NCT ID: NCT00375089 Completed - Obesity Clinical Trials

Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity

Start date: September 2006
Phase: N/A
Study type: Observational

Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people in the United States. As the most commonly identified genetic cause of obesity, PWS is often confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS, but clinically do not have PWS. The purpose of this study is to evaluate the clinical features and genetic basis of PWS and EMO, and to determine how these conditions affect a person throughout a lifetime.

NCT ID: NCT00361985 Withdrawn - Morbid Obesity Clinical Trials

Study of Proton Pump Inhibitors (PPI) to Prevent Strictures After Gastric Bypass Surgery

Start date: January 2008
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether suppressing acid production by administration of daily proton pump inhibitors in the early post-operative period will reduce the gastrojejunal anastomosis stricture rate in patients undergoing laparoscopic gastric bypass surgery for morbid obesity.

NCT ID: NCT00356213 Completed - Morbid Obesity Clinical Trials

Comparison of Laparoscopic Sleeve Gastrectomy and Roux-Y-gastric Bypass in the Treatment of Morbid Obesity

Start date: October 30, 2006
Phase: N/A
Study type: Interventional

The laparoscopic sleeve-gastrectomy (SG) compared to laparoscopic proximal Roux-Y-gastric bypass (PGB) is as successful in the treatment of morbid obesity in the majority of patients. In case of insufficient weight loss malabsorption can to be added by performing laparoscopic bilious-pancreatic diversion duodenal switch (BPD). The resection of the gastric fundus (LG) leads to changes in gastrointestinal hormones that are possibly different to bypassing the fundus (PGB).

NCT ID: NCT00351338 Recruiting - Morbid Obesity Clinical Trials

Nutritional Deficiencies in the Bariatric Patients

Start date: July 2006
Phase: N/A
Study type: Observational

Although morbidly obese subjects have larger than regular caloric intake, there is evidence that they suffer from nutritional deficiencies at a higher rate than the general population, probably because they eat mostly "unhealthy food."

NCT ID: NCT00346879 Withdrawn - Morbid Obesity Clinical Trials

Study to Determine Effective Dosing of Fondaparinux in Obese Persons

Start date: August 2006
Phase: Phase 1
Study type: Interventional

This is a prospective open-label study comparing two dosing regimens of fondaparinux, which is used to prevent deep vein thrombosis, in morbidly obese volunteers.

NCT ID: NCT00331565 Completed - Morbid Obesity Clinical Trials

Investigations on the Influence of Bariatric Surgery on the Metabolism and Absorption of Atorvastatin

Start date: August 2006
Phase: Phase 4
Study type: Interventional

Altered bioavailability of drugs will potentially affect both drug efficacy as well as safety. In patients subjected to bariatric surgery due to morbid obesity the gastro intestinal tract is considerably reconstructed and a change in drug bioavailability is very likely. Getting further knowledge on important mechanisms responsible for altered bioavailability would help in predicting clinically relevant consequences on different drugs. In the present study we aim to investigate the effect of bariatric surgery on atorvastatin bioavailability. Atorvastatin is subjected to both extensive metabolism and drug transport and will potentially be a good predictor for mechanisms relevant for other drugs as well. In addition will the expression of different enzymes and transporters be measured in the gastrointestinal tract and in the liver to elucidate on mechanism behind the eventual effects.