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Obesity, Morbid clinical trials

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NCT ID: NCT01695083 Completed - Morbid Obesity Clinical Trials

Non Invasive Measurements of Fibrosis, Inflammation and Steatohepatitis in Morbidly Obese Patients

FIRM
Start date: October 2012
Phase:
Study type: Observational

Abstract: Fatty liver most frequently corresponds to a fat overload of the liver. It is usually classified as alcoholic steatosis or non-alcoholic steatosis. In the case of non alcoholic fatty liver overload, the histological spectrum ranges from simple steatosis to steatohepatitis (NASH) which associates inflammation to steatosis, with a risk of progression to fibrosis and cirrhosis. Obese patients are at particular risk of NASH. Screening of these hepatic lesions is difficult especially as they may exist while the liver tests are normal. The diagnosis of NASH is currently done by liver biopsy, which exposes them in particular to the risk of hemorrhagic complications. Number of subjects required: According to the literature and data collected Louis Mourier in the recent years, the inclusion of 200 patients would examine 20-40 patients with severe histological steatosis and steatohepatitis. All patients will be included in Louis Mourier hospital. Follow-up: one month Search duration: 37 months Duration inclusions: 36 months The total duration of participation for a patient will be one month. Methodology: It is a monocentric, prospective study evaluating the value of noninvasive tests for the diagnosis of hepatic lesions in morbid obese patients. The "open " MRI system allows access to MRI for all obese patients (maximum weight 250 kg). Three of such systems are available in France and liver pathology can be explored only on the system of Louis Mourier. The reference method is liver histology; studied tests are abdominal MRI, Fibroscan / CAP, and serum tests. Examinations required specifically for research Examinations required specifically for the research is abdominal MRI, FibroScan/ CAP and serum tests. Primary endpoint : To validate the use of abdominal MRI, the FibroScan/ CAP and serum tests for finding severe steatosis and / or NASH, specificity, sensitivity, positive and negative predictive values of these tests are calculated. The gold standard is the result of histology on liver biopsy, with a morphometric study of these parameters. ROC curves are used to determine the best compromise between sensitivity and specificity. The secondary endpoints were: Histological lesions of liver fibrosis. Quantification of abdominal fat by MRI (in the form of three variables of interest: quantification of the surface of the visceral fat, of subcutaneous fat and of intrahepatic fat assessed by the percentage loss of signal

NCT ID: NCT01690728 Completed - Morbid Obesity Clinical Trials

Effect of Physical Activity on Weight Loss and Cardiovascular Risk Factors After Gastric Bypass

Start date: October 2012
Phase: N/A
Study type: Interventional

The aim of this study is to increase our knowledge about the effect of physical activity in patients who have undergone gastric bypass surgery. The study will provide novel information in two areas. The main objective is to study the effect of physical activity on the weight loss and cardiovascular risk factors. This will be accomplished in a randomized clinical trial in patients, who are eligible for gastric bypass (GB). Patients will be randomized to six month of structured physical activity or standard postoperative counseling. The study will include an exhaustive panel of blood tests related to cardiovascular risk and the most extensive evaluation of structural and functional vascular test done in this patient group so far. In addition the study will provide information of the effect of bariatric surgery per se since both pre- and postoperative investigations are conducted. The study will learn us to what degree it is possible to motivate this group of patients to increased physical activity. All together this will enable us to improve the counseling of the patients undergoing GB.

NCT ID: NCT01686997 Completed - Morbid Obesity Clinical Trials

Effect of Long Biliopancreatic Limb RYGB on Weight Loss and Comorbidities

Elegance
Start date: July 2012
Phase: N/A
Study type: Interventional

Morbid obesity is an increasing medical problem in the western countries. It's related to comorbidities as diabetes mellitus, hypertension, OSAS, arthrosis and hypercholesterolemia. The Roux-en-Y Gastric Bypass (RYGB) is an effective surgical therapy for morbidly obese patients. A part of these patients will have disappointing results, and have weight regain on the long term. Some studies show more weight reduction by increasing the biliopancreatic limb in patients with morbid obesity. The objective of this study is to investigate the effect of variations in the length of biliopancreatic limb on weight reduction in morbidly obese patients undergoing RYGB-surgery. We hypothesize that longer biliopancreatic limb results in more weight reduction. The study design is a prospective, randomized control trial. The patients will be randomized in 2 groups: a standard RYGB (short biliopancreatic limb) and long biliopancreatic limb RYGB.

NCT ID: NCT01686919 Withdrawn - Obesity, Morbid Clinical Trials

Effect of Milk-free Diet on Weight and Irritable Bowel Syndrome in Morbid Obesity

Start date: December 2012
Phase: N/A
Study type: Interventional

Innlandet Hospital in Gjøvik is a center for patients suffering from morbid obesity in Hedmark og Oppland, Norway. Patients with either BMI > 40 kg/m2 or with BMI > 35 kg/m2 and complications who opt for "gastric bypass" surgery, go through a standard program including a thorough clinical examination and information on the operation, followed by a learning and coping program that consists of standard dietary advise for weight loss and includes weekly visits during 8 weeks. This research project concerns a subgroup in the patient population described above: morbidly obese patients with irritable bowel syndrome (IBS). In this group it will be investigated how an 8 week preoperative milk-free diet affects digestive functions and weight loss. It is known that milk may cause stomach complaints and may make it more difficult to loose weight.

NCT ID: NCT01685177 Recruiting - Morbid Obesity Clinical Trials

Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient

SADI vs CD
Start date: September 2009
Phase: N/A
Study type: Observational

Single-Anastomosis Duodeno-Ileal bypass with a 250 cm common/alimentary loop is a modification of standard duodenal switch in which a Roux-en-Y duodeno-ileal anastomosis is performed at 250 cm from the cecum and a 60 cm to 100 cm common channel is build up. Hypothesis of the study is that Single-Anastomosis Duodeno-Ileal bypass behaves at least equally to standard duodenal switch as a second step after sleeve gastrectomy in the super-morbid patient. Secondary aims are to demonstrate that single-anastomosis duodeno-ileal bypass is simpler to perform, quicker and has less postoperative short, mid and long-term complications.

NCT ID: NCT01684280 Completed - Morbid Obesity Clinical Trials

Obesity-related Genes in Taiwanese Undergoing Weight Loss

Start date: June 2010
Phase: N/A
Study type: Observational

To investigate: 1. Associations between miRNA and insulin signaling-related gene expressions in abdominal adipose tissues in obese subjects. 2. Differences in miRNAs expressed by intrabdominal omental adipose tissues between genders.

NCT ID: NCT01676883 Completed - Obesity, Morbid Clinical Trials

Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons

Start date: October 2012
Phase: N/A
Study type: Interventional

Studies have confirmed the association between plantar callosities and severely obese individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for estimating body composition because it is easy to use, noninvasive, relatively inexpensive, and can be performed across a wide range of subjects. Our hypotheses for this study are: (1)plantar callosities influence the body composition measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the percentage of body fat compared with air-displacement plethysmography (BodPod).

NCT ID: NCT01675713 Completed - Morbid Obesity Clinical Trials

Lifestyleintervention for the Treatment of Severe Obesity

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

The overall purpose of this project is to study the acute, short- (≤ 1 year) and long- (> 1 year) term effects on body composition and psychological health after a 10 to 14-weeks comprehensive lifestyle modification program for the treatment of severe obesity. The aims of the PhD project are to investigate whether an intensive lifestyle intervention leads to acute and short term (< 1 year) changes in: 1. The BMI/Weight 2. Body composition (waist circumference, fat mass, fat free mass, skeletal muscle mass and visceral fat area) 3. Psychosocial factors such as eating behavior, anxiety and depression symptoms and health-related quality of life

NCT ID: NCT01652131 Recruiting - Obesity Clinical Trials

Behaviour of Intravenous Solutions in Obese Patients Under General Anesthesia

Start date: May 2012
Phase: N/A
Study type: Interventional

There is no objective evidence of how long intravenous solutions remain inside venous blood vessels after they have been administered, therefore there is no definite guideline of how to administer them in the preoperative setting. Besides, obese patients represent a particular group of subjects as they theoretically with-hold a constant inflammatory response and that would modify the way solutions behave intravenously, that is how long they remain inside. Having said this, we wish to describe the way colloid solutions behave in this group of patients by taking serial blood samples in 12 obese patients after a colloid infusion, to calculate plasma dilution curves based on hemoglobin dilution and therefore infer the time it remains intravascularly. All this in the hope this information will help, in the near future, to establish a more objective way to use these solutions and avoid possible complications due to over-administration.

NCT ID: NCT01652105 Not yet recruiting - Morbid Obesity Clinical Trials

Randomized Trial of Preoperative Diets Before Bariatric Surgery

Start date: September 2012
Phase: N/A
Study type: Interventional

Randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and Prodimed (VLCD) in 100 morbidly obese patients selected for a gastric bypass procedure