Obesity Clinical Trial - EndoBarrier in Obese Subjects With Type 2

Status Completed

Clinical Trial Summary

The aim of the study is to explore short and longer-term effects of the Endobarrier™ implantation on insulin resistance and beta-cell function assessed by repeated Botnia clamps. In addition changes in gut peptides and gut permeability after implantation of a removable duodeno-jejunal bypass device to induce diabetes remission in obese subjects with sub-optimally controlled type 2 diabetes mellitus will be determined. Further changes in body weight and body composition, the change in global cardiovascular risk from baseline to 12 months, estimated using the UKPDS risk engine will be recorded.

Clinical Trial Description

Obesity and diabetes probably represent the most challenging threat to public health in the 21st century. Obesity has multiple deleterious effects on health, significantly increasing the risk of fatal and non-fatal diseases including type 2 diabetes (T2DM). Bariatric surgery is a well-established method for the treatment of morbid obesity and has increasingly been recognized as an effective, long-lasting treatment option for T2DM. Recently a potential, non-invasive alternative to bariatric surgery, a duodenal-jejunal bypass liner (EndoBarrierTM) has been introduced. It is an endoscopically implantable and removable device that prevents contact between partially digested nutrients and the proximal intestine. This device was shown to reduce body weight and to improve glycaemic control in subjects with diabetes. Small pilot studies suggested a change in incretin levels, similar to that observed after gastric surgery with an improvement of insulin sensitivity and glucose metabolism. To better understand and characterize the hormonal and/or metabolic effects after the implantation and removal of the EndoBarrierTM, this monocentric, prospective, trial is being performed. The primary objective of this study is to clarify the changes in gut peptides and gut permeability after implantation the EndoBarrierTM in obese subjects with sub-optimally controlled type 2 diabetes mellitus. Additionally, the investigators aim to determine the changes in body weight and measure of adiposity, the change in global cardiovascular risk from baseline to 12 months as well as the changes in insulin sensitivity and beta-cell function over time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02769728
Study type	Interventional
Source	Medical University of Graz
Contact
Status	Completed
Phase	N/A
Start date	February 2016
Completion date	January 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04101669` - EndoBarrier System Pivotal Trial(Rev E v2)	N/A
Recruiting	`NCT04243317` - Feasibility of a Sleep Improvement Intervention for Weight Loss and Its Maintenance in Sleep Impaired Obese Adults	N/A
Terminated	`NCT03772886` - Reducing Cesarean Delivery Rate in Obese Patients Using the Peanut Ball	N/A
Completed	`NCT03640442` - Modified Ramped Position for Intubation of Obese Females.	N/A
Completed	`NCT04506996` - Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management 2	N/A
Recruiting	`NCT06019832` - Analysis of Stem and Non-Stem Tibial Component	N/A
Active, not recruiting	`NCT05891834` - Study of INV-202 in Patients With Obesity and Metabolic Syndrome	Phase 2
Active, not recruiting	`NCT05275959` - Beijing (Peking)---Myopia and Obesity Comorbidity Intervention (BMOCI)	N/A
Recruiting	`NCT04575194` - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy	Phase 4
Completed	`NCT04513769` - Nutritious Eating With Soul at Rare Variety Cafe	N/A
Withdrawn	`NCT03042897` - Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer	N/A
Completed	`NCT03644524` - Heat Therapy and Cardiometabolic Health in Obese Women	N/A
Recruiting	`NCT05917873` - Metabolic Effects of Four-week Lactate-ketone Ester Supplementation	N/A
Active, not recruiting	`NCT04353258` - Research Intervention to Support Healthy Eating and Exercise	N/A
Completed	`NCT04507867` - Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III	N/A
Recruiting	`NCT03227575` - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control	N/A
Completed	`NCT01870947` - Assisted Exercise in Obese Endometrial Cancer Patients	N/A
Recruiting	`NCT05972564` - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function	Phase 1/Phase 2
Recruiting	`NCT06007404` - Understanding Metabolism and Inflammation Risks for Diabetes in Adolescents
Recruiting	`NCT05371496` - Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

EndoBarrier in Obese Subjects With Type 2 Diabetes Mellitus

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms