Technical Summary: Diabetes
WellGen, Inc. Abridged Technical Summary
Inflammation and Diabetes Medical Food
Nutrigenomics and Discovery Platform
This technical summary provides support in the form of references for the exciting new application of WG0401, WellGen’s lead candidate medical food product, for Type 2 Diabetes. WG0401 is a proprietary natural anti-inflammatory derived from black tea that has been developed through WellGen’s research program.
A single authoritative work is commercially available and extensively reviews the chemistry, biology and health-promoting properties of tea. The book was produced independently of WellGen scientists and is edited by leading natural product and nutrition experts. One of the authors, Dr Chi-Tang Ho, is a scientific advisor to WellGen:
Chi-Tang Ho (Ed), Jen-Kun Lin (Ed), Fereidoon Shahidi (Ed); “Tea and Tea Products: Chemistry and Health-Promoting Properties”, Nutraceutical Science and Technology Series, Taylor and Francis Inc, July 2008.
1. Inflammation is associated with development of diabetes and complications »
A growing body of research suggests that inflammatory mechanisms contribute to the development of diabetes and progression of complications such as atherosclerosis, kidney failure and vision loss. Therapeutic effects of aspirin in the treatment of diabetes were first reported over 100 years ago (Williamson 1902), and recent studies demonstrate improved insulin sensitivity and lower fasting glucose levels following treatment with salicylates (Cai et al, 2005; Koska et al, 2008; Fleischman et al, 2008; Hundal et al, 2002). However, the clinical use of these compounds is limited due to their adverse gastrointestinal effects. Clearly, there is an unmet need for a safer anti-inflammatory agent that provides additional glycemic control in individuals with or at risk for diabetes.
2. Oxidative stress is implicated in progression of diabetes and complications »
Microvascular complications include retinopathy, nephropathy, sensory neuropathy, and periodontal disease. These complications occur frequently, and diabetes is the leading cause for the development of blindness in adults (age 20-74), kidney failure, and non-traumatic lower limb amputations (NIH 2008). An emerging hypothesis to account for the persistence of these complications, even with acceptable glycemic control, proposes that even intermittent hyperglycemia results in increased steady-state levels of reactive carbonyl compounds, formed by oxidative or nonoxidative reactions (Baynes and Thorpe, 1999). According to the reactive carbonyl hypothesis, these reactive compounds induce tissue damage through oxidative stress and chemical modification of proteins (Baynes and Thorpe, 1999). This hypothesis is supported by animal studies reporting an observed delay in disease progression following treatment with agents that trap RCS (Baynes and Thorpe, 1999). Clinical studies examining the efficacy of agents that prevent the formation of these reactive compounds or reduce their levels are in progress.
3. Inflammation is targeted for drug development in diabetes »
There is a growing body of in vitro and in vivo studies that support the role of inflammatory processes in the development of insulin resistance and the progression of diabetic complications (King 2008). Recent studies demonstrate improved insulin sensitivity and lower fasting glucose levels following treatment with salicylates (Cai et al, 2005; Koska et al, 2008; Fleischman et al, 2008; Hundal et al, 2002). However, the clinical use of these compounds is limited due to their adverse gastrointestinal effects. Therefore, there are ongoing clinical studies targeting specific inflammatory pathways for drug development in diabetes.
4. Inflammation is the target for WellGen medical food development in diabetes »
The emerging view from the studies described above is that inflammation plays an important role in the development of diabetes and diabetic complications. This suggests that an anti-inflammatory agent with minimal gastrointestinal effects could have therapeutic value in the prevention and/or management of diabetes with advantages over nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin. WG0401 is positioned to meet this need, as the anti-inflammatory properties of theaflavin and theaflavin-enriched BTE have been demonstrated in vitro, in vivo in animal models, and in clinical trials. These studies indicate that, rather than acting to eliminate the activity of a single step in the inflammatory process, theaflavins modulate multiple steps in the inflammatory cascade to help restore a healthy balance.
5. Theaflavins/WG0401 reduce inflammation in vitro and in vivo »
A single authoritative work is commercially available and extensively reviews the chemistry, biology and health-promoting properties of tea. The book was produced independently of WellGen scientists and is edited by leading natural product and nutrition experts. One of the editors, Dr Chi-Tang Ho, is a scientific advisor to WellGen:
Chi-Tang Ho (Ed),
Jen-Kun Lin (Ed),
Fereidoon Shahidi (Ed);
“Tea and Tea Products: Chemistry and Health-Promoting Properties”, Nutraceutical Science and Technology Series, Taylor and Francis Inc, July 2008.
6. WG0401 contains theaflavins and catechins (including EGCG) that are antioxidants and have been demonstrated to reduce reactive carbonyl species (RCS) and reactive oxygen species (ROS) in vitro and in vivo »
7. Theaflavins modulate blood lipids »