A double-blind placebo-controlled pilot study of daily oral supplementation of lysulinÃÂ® in people with type 2 diabetesAuthor(s): John F Burd*, Vivianne Noetzel, Adriana Gonzalez and Francisco Alberto Alvarez Melero
Objective: This Pilot Study is aimed at evaluating the effect of daily oral supplementation with Lysulin® on glycemic control as assessed by measurement of Hemoglobin A1c (A1c), cardiometabolic and anthropometric parameters as compared to Placebo in people with Type 2 diabetes. This is a Pilot Study and it is intended to be used to design a further confirmatory clinical study by providing information on the feasibility of recruitment, randomization, sample size, retention, and assessment of procedures, methods and implementation of a novel intervention: Lysulin. Methods: A randomized, double-blind placebo-controlled pilot study was conducted over a 12-week period in 67 subjects. Subjects enrolled in the study had average an A1c 8.5 (2.2) and range 5.1%-12.9% at baseline. The inclusive range of low, medium and high in A1c levels was chosen to evaluate if there was a biased response to a specific A1c level. Subjects of ages 49 (9) years with a range of 33-74 years and both sexes (31 women and 36 men) were included in the study. Subjects were randomized 1:1:1 into groups based on oral supplementation: Group A Placebo, Group B 2.22 g/day Lysulin Group, Group C 3.33 g/day Lysulin. Subjects were evaluated at Baseline and at 4, 8 and 12 weeks. The primary endpoint of this pilot study changed in A1c from baseline to week 12. For observation purposes, Groups B and C were followed to 26 weeks. The data will be presented as Average followed by Standard Deviation in parenthesis where appropriate. Results: The results revealed a statistically significant reduction in A1c in the two groups taking Lysulin (Group B p<0.02 and Group C p<0.004) as compared to the placebo group. Changes in A1c were observed for some subjects in as little as 4 weeks after initiation of Lysulin supplementation. At 12 weeks, the change in A1c for Group A was 0.03%, the change for Group B was -0.30% and the change for Group C was -0.97%. For Group C, 65% of the subjects responded to Lysulin with a change of -1.64% A1c in 12 weeks and change of -1.91% in 26 weeks. The results also revealed a statistically significant reduction in Systolic (p<0.04) and Diastolic (p<0.05) Blood Pressure for study subjects in Group C. Clinically significant improvement was also seen in triglycerides in Group C. Conclusion: Daily oral supplementation with Lysulin has a statistically significant reduction in A1c in subjects diagnosed with Type 2 diabetes. Statistically significant improvement in systolic/diastolic blood pressure was also observed. The study revealed that the optimum dose of Lysulin is 3.33 g/day. Further confirmatory clinical studies are planned to verify the results observed in this study.