Clinical trial design and process
impaired fasting blood sugar, T2D
MAY
This study is a single-center, randomized, double-blind, placebo-controlled clinical trial. All processes were conducted at a single center (Kyung Hee University Hospital, Seoul, South Korea) from Feb. 15. 2015 (1st patients screened) to May. 5. 2015 (last patients completed). A total of 113 volunteers with impaired fasting blood sugar and mild T2D participated in the screening procedure, of which 72 participants met the inclusion and exclusion criteria and were enrolled in this study. To calculate the effective number of participants, the following assumptions were employed.The statistical hypothesis test of the evaluation variable is a one-sided test.Level of significance is 5%Type 2 error (β) is set to 0.2 and the power of the test is maintained at 80%.The ratio of the number of test samples between the test group and the control group, e.g., (Jesus of the test group) = (Jesus of the control group), 1:1.After ingestion of test food, functional evaluation variables of the test group and the control group were compared.To estimate the number of participants, the criteria for evaluating the blood glucose lowering function was used as in the human application test [The hypothesis is as follows:µt = µc (After the test, the measured value of the endpoint of the test group is the same as that of the control group)H1: µt < µc (After the test, the measured value of the endpoint of the test group is less than that of the control group).Assuming the above (1)-(5), the number of test samples required for the clinical trial is as follows (one-sided test):Formula for calculating the number of participants is expressed by the difference in the resulting variable as below,(σ: standard deviation of the post-treatment change value in the previous trial, E: judged to be clinically significant, α = 0.05 (Zα = 1.645), β = 0.2 (Zβ = 0.840), σ = 5.4).When the number of participants was calculated as follows by the above equation, the minimum number of participants is about 23 per group.The effective number of samples is 23 x (120/100) x (130/100) = 35.88, when calculated by considering the 20% dropout rate and 30% compliance rate in the obtained sample number. Thus, the number of participants to be enrolled in each group is 36, and the total number of participants is 72.The 72 selected participants were randomly assigned to the test group or control group at a ratio of 1:1 based on the following steps: (1) Patients selected as study participants were assigned to each group using a randomization method based on probability. (2) Random allocation table using a function that generates a random number of the SPSS program. (3) One of the two groups was assigned from the lowest number in the order of date of visit (Day 0). The random number (RN) was assigned according to the randomization table in the order of participation in the group to be assigned to the test group or the control group. (4) The administering pharmacist applied the medication to be administered to the participants according to the randomization plan, which was provided according to the code given to the participants. (5) The randomization of blocks using random code program of statistical program was designed to have the same number of participants.All physicians and outcome assessors were blinded to randomization allocation. During the experiment, neither the investigator nor the participants were aware of each participant was assigned to, and they did not remove their blindfolds until a medical emergency occurred to protect the privacy of the assigned group. To ensure this, research activities, including screening, enrollment, informed consent, baseline data collection, randomization, and medication administration, were conducted solely by research personnel.All participants were visited at the initial screening (visit 1), baseline (visit 2), 6 weeks (visit 3), 12 weeks (visit 4), and follow up period. After randomly assigning the participants to the CLM group (