Abstract
Cyclo (his-pro) plus zinc (Cyclo-Z) treatment improved insulin and leptin sensitivity without any known side effects in animal studies. We now report the results of a randomized, double-blind, placebo-controlled multicenter FDA approved phase 2a clinical trial with obese diabetic subjects. A total of 64 subjects with hemoglobin A1c (HbA1c) levels between 7.5 and 10 and body mass index (BMI) above 30 were recruited in 4 different treatment groups: A:3 mg CHP, B:9 mg CHP; or C:15 mg CHP plus 23 mg zinc in all three treated groups; D: placebo to take one capsule by every subject at bedtime daily. HbA1c, OGTT, plasma insulin and leptin levels, were determined every 4 weeks while body weight, BMI and side effects were determined every 2 weeks. During the 12-week study period, HbA1c levels changed from baseline at 12 weeks as A: -0.247 ± 0.198 %; B: -0.233± 0.282%; C: -0.586± 0.250%; D: 0.05 ± 0.248%. p=0.0824 C vs. D. Body weight changed. A:0.479 ± 1.032 kg; B: 0.738 ± 0.784 kg ; C: -0.962 ± 0.6 29 kg ; D: 1.456 ± 0.772 kg. P=0.0249 C vs. D. TAFGC (OGTT) changed. A: -2.675 ± 10.336 mg/dL/hour; B: -2.399 ± 8.197 mg/dL/hour; C: -14.895 ±5.751mg dL/hour; D:0.8475 ± 13.515 mg/dL/hour. p=0.039 C vs. D. BMI changed. A: -0.089± 0.358 kg/m2; B: 0.008± 0.186 kg/m2; C: -0.291 ± 0.186 kg/m2; D:1.023 ± 0.493 kg/m2. P=0.049 C vs. D. Plasma insulin levels changed. A:4.269 ± 8.115 µU/mL; B: 2.787 ± 2.566 µU/mL; C: -5.0 ± 10.795 µU/mL; D: 29.787± 28.513 µU/mL. P=0.0296 C vs. D. Plasma leptin levels changed. A:0.25 ± 1.065 ng/mL; B: -3.42 ± 1.488 ng/mL; C: -3.386± 0.784 ng/mL; D:0.377 ± 1.12 ng/mL. P=0.010 C vs. D. No Adverse side effects were detected in any group. Cyclo-Z containing 15 mg CHP plus 23 mg zinc appears to be the most effective dose and safe for the treatment for both diabetes and obesity through improving insulin resistance and leptin resistance. FDA IND:061897. Disclosure M.K. Song: Stock/Shareholder; Self; NovMetapharma Inc in Korea (Investor company). Funding NovMetaPharma Co., Ltd.
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