Prediabetes Clinical Trial
Official title:
Study on the Mechanisms of Soluble Dietary Fiber Extracted From Jerusalem Artichoke in the Treatment of Pre-type 2 Diabetes
The trial was a multicenter, randomized, double-blind, placebo-controlled,
parallel-controlled, exploratory clinical study.Through the intervention of soluble dietary
fiber in the pre-type 2 diabetic population, the change of blood glucose spectrum before and
after intervention can show the effect of this intervention on the outcome, and further
elucidate the effect of soluble dietary fiber intervention on the level of insulin resistance
and its effect on outcome. Helps to prevent the more scientific and effective prevention of
type 2 diabetes from pre-diabetes.
Subjects who met the criteria were randomly divided into the experimental group and the
control group, after 24 weeks of intervention, the incidence of blood sugar reversion to
normal was main observed.The main purpose of this study was to investigate the effect of
soluble dietary fiber treatment regimens on the conversion rate of pre-type 2 diabetes
(converted to normal blood glucose, type 2 diabetes, or stable in the stage of impaired
glucose tolerance). The secondary objective was to study the improvement of insulin
resistance and changes in intestinal flora after intervention.
The soluble dietary fiber (NIUCHANG®) and placebo used in the trial were exclusively produced
by Inuling (Beijing) Technology Co., Ltd. and provided free of charge. During the treatment
period, the treatment group was given oral "NIUCHANG®" (once 15g,once a day)and the control
group was given oral placebo (once15 g, once a day) for 24 weeks.
The test was performed for 12 weeks as a course of treatment。At the end of one course of
treatment, if the glucose tolerance was changed to normal or the blood glucose was stable in
the pre-diabetes phase, the original dose was maintained and continued for 12 weeks. At 24
weeks, patients with normal blood glucose and glucose tolerance tests were followed up for 48
weeks. At the end of one course of treatment, if the blood glucose progresses to the stage of
diabetes, the test is withdrawn and treated according to clinical routine.
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