The role of individual leukocyte populations in type 2 diabetes (T2D) and immunometabolism in general represent important gaps in knowledge to better understand the etiopathogenesis of T2D. Emerging evidence indicates that certain leukocyte populations serve as an important nexus of T2D-associated inflammation. This novel and innovative clinical trial will test the efficacy of a leukocyte-selective anti-inflammatory small drug as adjunctive therapy in improving insulin sensitivity in obese, insulin-resistant type 2 diabetic subjects. This trial also offers a first-in-kind opportunity to better understand the role of specific leukocyte populations in type 2 diabetes. The drug?s clinical profile suggests that it will be well-tolerated with few, if any, side effects, and the existence of simple methods that can indirectly measure its activity in vivo.

Public Health Relevance

Globally, type 2 diabetes incidence as well as direct- and indirect health care costs are increasing substantially. Obesity, the primary disease risk factor, leads to inflammation that none of the currently-available drugs can efficaciously control without significant side effects. The proposed leukocyte-selective anti-inflammatory small drug, as an adjunctive treatment to standard-of-care therapy, offers a unique therapeutic option to mitigate inflammation and increase insulin sensitivity, potentially improving glucose control beyond that of standard-of-care agents alone while delaying the time to the deleterious disease-related complications. This clinical trial offers a novel direction for T2D therapy and potentially for other disorders of inflammation-associated metabolism.

Agency
National Institute of Health (NIH)
Institute
National Center for Advancing Translational Sciences (NCATS)
Type
Exploratory/Developmental Cooperative Agreement Phase II (UH3)
Project #
5UH3TR001372-02
Application #
9110304
Study Section
Special Emphasis Panel (ZTR1)
Program Officer
Colvis, Christine
Project Start
2015-07-15
Project End
2017-04-30
Budget Start
2016-05-01
Budget End
2017-04-30
Support Year
2
Fiscal Year
2016
Total Cost
Indirect Cost
Name
Allegheny-Singer Research Institute
Department
Type
DUNS #
033098401
City
Pittsburgh
State
PA
Country
United States
Zip Code
15212