The subjects who showed relative reductions in CRP were diabetics on metformin, the most common drug used to treat diabetes. The diabetics were twice as likely to have a reduction in CRP levels, as compared with other subjects in the "Flint" study who had other non-diabetes medical disorders. After one month of supplementation, CRP levels dropped in 26% of the subjects with diabetes, compared with a drop in CRP levels in 12% of the general trial population of subjects who did not have diabetes. The goal of the study was to find specific sub-populations in which the Anatabloc® supplement might be of benefit; therefore, this finding, though based on a small number of diabetics (18 in the total study population), is very encouraging. The investigators are currently evaluating whether to modify the rest of the study or conduct a study focused on diabetes.
Elevated CRP is predictive in other studies for the onset of both metabolic syndrome as well as overt diabetes, and elevated CRP is a significant risk factor for cardiovascular disease both in diabetics and non-diabetics. Lowering CRP would be strong evidence of a potential benefit in reducing the inflammatory component in adult onset diabetes, an epidemic problem in the United States.
Dr. Michael Mullan, MD, PhD, of the Roskamp Institute that sponsored the study, said, "We are still looking at the data to define which interleukins are most strongly affected, but when we conducted the CRP breakout analysis by disease, the late onset diabetics showed a strong statistical trend to have lower CRP with anatabine treatment compared to the non-diabetics. It will take more work beyond this interim look to confirm this in a larger sample."
464 subjects have been screened for the "Flint" study, and 117 subjects have completed the study.