Diabetes affects more than 9% of Americans and costs over $300 billion in 2017 in USA. Medical therapies have limitations in treating diabetic patients with obesity due their common side effects of weight gain. Bariatric surgery has been proposed for treating diabetic patients with promising outcomes. In this project, we propose a novel method of intestinal electrical stimulation (IES) for treating diabetes. Physiologically, the effects of the proposed IES have been shown to be resemble to bariatric surgery, including reduction in absorption and food intake, and enhanced secretion of glucagon like peptide-1 (GLP-1). The completion of our Phase I project and other recent studies has demonstrated promising hypoglycemic effects of the proposed IES and mechanisms involving gastrointestinal hormones and ? cell functions. These findings have led us to believe that IES is a viable therapy for diabetes. Accordingly, we propose to design and develop a novel IES system in this project.
The aim of this project is to develop an innovative implantable pulse generator (IPG) and a special intestinal catheter to be used for screening patients. The proposed system will work as follows: once a potential patient with diabetes is identified, he or she will be screened non-surgically using an intraluminal catheter to determine the responsiveness. If the test indicates a good response to IES, a permanent IPG will be placed laparoscopically. The IES will be delivered automatically upon food intake for a few hrs. To achieve maximum efficacy, each electrical stimulus will be delivered upon the detection of an intrinsic small intestinal myoelectrical wave, a method called synchronized IES. An IPG incorporated with two special features will be designed and developed, one to automatically detect food intake and the other to detect peak of intrinsic intestinal myoelectrical activity for synchronization. With these imbedded algorithms, on-demand closed-loop IES is made feasible. Secondly, a special intraluminal catheter will be designed and developed. It can be used to perform IES without any surgical procedures and screen patients for permanent IES therapy. The PI has assembled a comprehensive and competitive team with expertise in neuromodulation, diabetes research, medical device development and software implementation.

Public Health Relevance

Diabetes is an epidemic health problem in the USA and around the world. In this project, a novel method of treatment is proposed by delivering weak electrical current to the small intestine to reduce blood glucose.

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Technology Transfer (STTR) Grants - Phase II (R42)
Project #
5R42DK100212-03
Application #
10017046
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Arreaza-Rubin, Guillermo
Project Start
2013-09-17
Project End
2021-06-30
Budget Start
2020-07-01
Budget End
2021-06-30
Support Year
3
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Transtimulation Research, Inc.
Department
Type
DUNS #
602492642
City
Oklahoma City
State
OK
Country
United States
Zip Code
73104