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Bariatric Surgery clinical trials

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NCT ID: NCT03460691 Not yet recruiting - Bariatric Surgery Clinical Trials

The Effect of Bariatric Surgery to Central Sensitization

Start date: March 9, 2018
Phase: N/A
Study type: Observational

Nowadays obesity is emerging as a very common health problem. It has been shown in various studies that obesity may be an important risk factor for the onset and progression of knee osteoarthritis (OA). The aim of this study is to determine the effects of bariatric surgery on knee pain, loss of function, quality of life and central sensitization.

NCT ID: NCT03455868 Recruiting - Clinical trials for Diabetes Mellitus, Type 2

Bone Health After Bariatric Surgery in Patients With Type 2 Diabetes

BODI
Start date: March 15, 2018
Phase:
Study type: Observational

Background: Bone fragility is a complication of type 2 diabetes. Diabetes treatments may ameliorate or deteriorate bone fragility in this population. Bariatric surgery is gaining in popularity in people with type 2 diabetes and may impact bone health. Objectives: To evaluate the impact of the most popular bariatric procedure worldwide (sleeve gastrectomy (SG)) on vBMD by QCT in patients with type 2 diabetes; Secondary aims: (1) to identify the determinants of vBMD after bariatric surgery in patients with type 2 diabetes; (2) to compare vBMD and its potential determinants after bariatric surgery with obese controls without diabetes as well as with controls without obesity and normoglycemia.

NCT ID: NCT03440138 Completed - Bariatric Surgery Clinical Trials

Defining Benchmarks in Bariatric Surgery

BBenchmarks
Start date: October 17, 2017
Phase:
Study type: Observational

Aim: To define benchmark outcomes in minimally-invasive primary bariatric surgery. Design: Multicenter retrospective cohort study. Assessed outcomes: Morbidity as defined by the Clavien-Dindo classification for surgical complications, the Comprehensive Complication Index® (CCI®) at discharge, at 3 months and at latest follow-up. Evolution of body mass index (BMI) will be also analyzed. Hospital eligibility: High volume centers (> 200 bariatric operations per year) from at least three continents, maintaining a prospective database, as well as having published previously critically on their outcome. Study population: Adult patients who underwent primary minimally invasive (laparoscopic / robotic) Roux-en-Y gastric bypass or sleeve gastrectomy from 1st of June 2012 to 31st of May 2017. Patient Exclusion criteria: detailed later. Data collection Deadline: 1st September 2017 - 30 April 2018

NCT ID: NCT03394638 Recruiting - Obesity Clinical Trials

Assessing the Value of eHealth for Bariatric Surgery

BePATIENT
Start date: February 21, 2017
Phase: N/A
Study type: Interventional

Bariatric surgery is the only treatment with long standing effect of morbid obesity. The key elements to success are the patient-selection, an experienced bariatric team and a completed follow-up program. Follow-up programs can consist of, for example, providing social support in support groups, teaching psychological skills, such as coping with the body change or teaching self-regulation of body weight. Furthermore, follow-up is important for dietary and sports counselling. The experience of the team members and coaching skills are essential in indicating the suitable procedure if necessary and guide the patients through the process. Various studies showed a significant positive effect of a completed follow-up program after bariatric surgery on maintaining weight loss. There is a burden for this on site provided care as organizational and financial resources are not unlimited. Especially as the follow-up period is an obligatory 5 years or if possible life long. Even if this aftercare is provided, not all patients complete the complete program. Various reasons are possible for an increasing no-show-rate, the loss of enthusiasm for onsite visits could be one of them. Analogue to other chronic diseases, the addition of telehealth could be useful. Telehealth is the delivery of health-related services and information via telecommunications technologies. It encompasses preventative, promotive and curative aspects. Examples are exchanging health services or education via videoconference, transmission of medical data for disease management (remote monitoring) and advice on prevention of diseases and promotion of good health by patient monitoring and follow-up. The participation of eHealth has been investigated and considered useful in the treatment of obesity. In a systematic review self-measured blood pressure monitoring was associated with better control of hypertension at least in the first year. Its value in a bariatric tract has not been investigated. It can be hypothesized that self-control by eHealth could enhance clinical outcome as more weight loss and comorbidity reduction. Long-term realistic goals setting, consistent use of routines and self-monitoring has been proven effective for weight loss maintenance. Patients with higher self-control are more certain regarding their abilities, which cause higher commitment and adherence to the program. This eventually leads to more weight loss. For this purpose an online monitoring program was designed for our Obesity Centre (BePATIENT) to provide preoperative information as well as aids in the post-bariatric phase by self-control wireless devices for registration of biometric outcomes, teleconference opportunities and access to additional information. In a prospective trial the implementation in several degrees is evaluated.

NCT ID: NCT03360565 Recruiting - Obesity Clinical Trials

Obesity: Prospective Evaluation of Upper Airway Obstruction and Compliance in Obese Patients in Pre and Post Bariatric Surgery

OBANEZ
Start date: March 2, 2016
Phase: N/A
Study type: Observational

This clinical trial is a monocentric, prospective, observational and controlled trial (historical cohort control group of healthy non-obese subjects who had Nasal functional exploration for Snoring) as part of current care. This study concerns the prevalence of obstructive sleep apnea syndrome (OSAS). OSAS is elevated in subjects with morbid obesity (BMI≥40) (on average 70%). International recommendations agree on the need to seek OSAS before bariatric surgery because of the high risk of complications. Increased nasal resistance could also be related to a limitation of inspiratory flow due to an abnormality of the elasticity of the nasal mucosa or "nasal compliance". Adipose infiltration of the nasal mucosa may occur during obesity. These tissue changes (decreased vaso-erectile tissue and increased adipose tissue) could modify the nasal compliance, which the decrease would be a possible factor of severity of OSAS in obese patients. Screening for an abnormality of compliance could also anticipate a difficulty of equipment for Continuous Positive Airway Pressure (CPAP) in the case of associated OSAS. All patients who must have bariatric surgery and get in the criteria are included. They will have to do a medical checkup pre and post-operative (polygraphy + ear/nose/throat assessment (ENT) + Nasal functional exploration). They will be followed for 13 to 24 months. The main objective of this research is to demonstrate a reduction of at least 30% of nasal compliance in a group of obese subjects (BMI> 35) compared to a control group of healthy subjects. The secondary objectives are to is to demonstrate an increase of 30% in resistance in patients with BMI> 35 compared to control group and a normalization of nasal compliance 1 year after surgery when their weight is normalized (BMI <30). A study period of 4 years is planned.

NCT ID: NCT03331536 Completed - Osteoporosis Clinical Trials

Skeletal Health in Bariatric Surgery Patients

Start date: March 22, 2018
Phase:
Study type: Observational

The investigators propose a prospective cohort trial that will help to understand the impact of Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) in pre- and post-menopausal female bariatric patients.

NCT ID: NCT03223389 Not yet recruiting - Type 2 Diabetes Clinical Trials

Fat Metabolites and Gut Hormones

Start date: August 7, 2017
Phase: N/A
Study type: Interventional

To investigate the effects of different fat metabolites on gut hormone secretion in gastric bypass operated subjects and BMI-matched controls.

NCT ID: NCT03203161 Not yet recruiting - Morbid Obesity Clinical Trials

Registry on Obesity Surgery in Adolescents

ROSA
Start date: September 2019
Phase:
Study type: Observational

While bariatric surgery is established as a safe and effective alternative with well-defined risks for severely obese adults, little has been published on its use in children. There are many unresolved questions concerning the long-term metabolic and psychological consequences of bariatric surgery in adolescents, and the difference with the adult population. The appropriate timing for bariatric surgery in young people, and the predictors of success and safety still need to be determined. The aim of this long-term prospective study is therefore to establish the safety and efficacy profile of surgical procedures and to clarify whether reductions in morbidity and mortality outweigh the risks of serious surgical complications and lifelong nutritional deficiencies.

NCT ID: NCT03200782 Completed - Bariatric Surgery Clinical Trials

Postprandial Hypoglycemia in Patients After Bariatric Surgery With Empagliflozin and Anakinra - The Hypo-BEAR-Study

Hypo-BEAR
Start date: May 30, 2017
Phase: N/A
Study type: Interventional

The purpose of the study is to investigate whether hypoglycaemia observed after food intake in bariatric patients can be either influenced by an SGLT2 inhibitor, empagliflozin, or via inhibition of inflammation with an human interleukin-1 receptor antagonist (IL1-RA, anakinra).

NCT ID: NCT03195504 Completed - Bariatric Surgery Clinical Trials

High-flow Nasal Oxygenation in Obese Patients During Apnea

Start date: August 10, 2017
Phase: N/A
Study type: Interventional

Before going off to sleep patients are given oxygen to saturate blood with oxygen to extend time before a decrease in the level of oxygen in the blood occurs. During this period, obese patients have a faster decrease in the level of oxygen in their blood. This study uses a device called "high-flow nasal cannula" (HFNC), which delivers humidified high-flow oxygen through 2 small plastic tubes placed just inside nostrils. In the intensive care unit settings this device has been used extensively and has become a standard practice. Purpose of this study is to determine whether these high-flow nasal cannula increase the time safely when going to sleep during elective surgery.