The study is part of a national clinical trial to determine the safety and efficacy of the device for possible treatment for overweight patients with type 2 diabetes.
Participants must be 18 to 70 years of age with type 2 diabetes and have a body mass index (BMI) between 28 and 45*. Those enrolled will undergo a laparoscopic procedure for implantation of the device, which requires an overnight stay at the hospital.
The device consists of a pulse generator that is implanted under the skin near the stomach and leads that are implanted in the gastric muscle. The treatment is based on a new technology called Gastric Contractility Modulation (GCM) that is designed to sense naturally occurring electrical activity of the stomach in real time and automatically apply electrical stimulation treatment during meal times.
The primary objective of the study is to evaluate the safety and efficacy of the device based on improvement in blood sugar levels (HbA1c), but impact on weight loss, blood pressure and other clinical and metabolic benchmarks will also be studied. The device will be implanted for at least 12 months and up to three years. Study subjects will be randomized into control or treatment groups, evaluated weekly and monthly at the beginning of the study, and then periodically for the remainder of the study.
The national epidemic of type 2 diabetes, most often associated with being overweight, continues to accelerate and affects more than 20 million Americans. About one million people are diagnosed with the metabolic disease annually.
Participants will receive all testing and study-related medical care at no cost and will be compensated for study-related expenses. After the first 12 months, participants will receive semi-annual evaluations for the remaining 2 years until a determination of safety and efficacy is made by the FDA. All information gathered during the study will be kept confidential.
The study is sponsored by MetaCure (USA), Inc., the company that developed the device, which is called the TANTALUS® system.
For more information, please call Colleen Sam at (310) 423-3779 or visit www.cedars-sinai.edu
*Body Mass Index (BMI) is a measure of body fat based on height and weight. Tables and calculation tools can be found at the National Heart Lung and Blood Institute website, which is www.nhlbisupport.com/bmi/
Europe’s Demographic Future. Where the Regions Are Heading after a Decade of Crises
10.08.2017 | Berlin-Institut für Bevölkerung und Entwicklung
Scientists reveal source of human heartbeat in 3-D
07.08.2017 | University of Manchester
Whether you call it effervescent, fizzy, or sparkling, carbonated water is making a comeback as a beverage. Aside from quenching thirst, researchers at the University of Illinois at Urbana-Champaign have discovered a new use for these "bubbly" concoctions that will have major impact on the manufacturer of the world's thinnest, flattest, and one most useful materials -- graphene.
As graphene's popularity grows as an advanced "wonder" material, the speed and quality at which it can be manufactured will be paramount. With that in mind,...
Physicists at the University of Bonn have managed to create optical hollows and more complex patterns into which the light of a Bose-Einstein condensate flows. The creation of such highly low-loss structures for light is a prerequisite for complex light circuits, such as for quantum information processing for a new generation of computers. The researchers are now presenting their results in the journal Nature Photonics.
Light particles (photons) occur as tiny, indivisible portions. Many thousands of these light portions can be merged to form a single super-photon if they are...
For the first time, scientists have shown that circular RNA is linked to brain function. When a RNA molecule called Cdr1as was deleted from the genome of mice, the animals had problems filtering out unnecessary information – like patients suffering from neuropsychiatric disorders.
While hundreds of circular RNAs (circRNAs) are abundant in mammalian brains, one big question has remained unanswered: What are they actually good for? In the...
An experimental small satellite has successfully collected and delivered data on a key measurement for predicting changes in Earth's climate.
The Radiometer Assessment using Vertically Aligned Nanotubes (RAVAN) CubeSat was launched into low-Earth orbit on Nov. 11, 2016, in order to test new...
A study led by scientists of the Max Planck Institute for the Structure and Dynamics of Matter (MPSD) at the Center for Free-Electron Laser Science in Hamburg presents evidence of the coexistence of superconductivity and “charge-density-waves” in compounds of the poorly-studied family of bismuthates. This observation opens up new perspectives for a deeper understanding of the phenomenon of high-temperature superconductivity, a topic which is at the core of condensed matter research since more than 30 years. The paper by Nicoletti et al has been published in the PNAS.
Since the beginning of the 20th century, superconductivity had been observed in some metals at temperatures only a few degrees above the absolute zero (minus...
16.08.2017 | Event News
04.08.2017 | Event News
26.07.2017 | Event News
18.08.2017 | Life Sciences
18.08.2017 | Physics and Astronomy
18.08.2017 | Materials Sciences