An interventional study of NIUCHANG and Placebo in Prediabetes, sponsored by Inuling (Bei Jing) Science and Technology Co. Ltd. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-01-07.
Sponsored by Inuling (Bei Jing) Science and Technology Co. Ltd · Not applicable, Interventional, and Prevention
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 At the end of one course of treatment, if the blood glucose progresses to the stage of diabetes, the test is withdrawn and treated according to clinical routine.
999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.
This study's enrollment of 246 is above the median of 65 across 844 interventional studies indexed under Prediabetic State.
Browse Prediabetic State studies →This is the only study on the registry with Inuling (Bei Jing) Science and Technology Co. Ltd as lead sponsor.
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The following various situations need to be met at the same time in order to be selected:
Exclusion Criteria:
Any of the following circumstances should be excluded and cannot be selected:
NIUCHANG（Soluble dietary fiber + prebiotics）：Oral, 1 bag (15g) once a day, taking 24 weeks
Dietary Supplement: NIUCHANG
Placebo（inactive drug ingredient）：Oral, 1 bag (15g) once a day, taking 24 weeks
Dietary Supplement: Placebo
Incidence of blood sugar reversal to normal after intervention
Through the intervention of soluble dietary fiber in the pre-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.
Time frame: Day 0, Week 24
Changes in insulin resistance index
the incidence of blood sugar reversion to normal was main observed
Time frame: Day 0, Week 24
Changes in intestinal flora
If the subject has had diarrhea or taking antibiotics 2 days before and after the fecal specimen should be taken, wait for the stagnation for 1 week before taking the stool specimen to reduce the interference of external factors.
Time frame: Day 0, Week1，Week4，Week12，Week 24
Incidence of blood glucose stabilization in pre-diabetes after intervention
blood glucose becomes stable
Time frame: Day 0, Week12，Week 24
Incidence of blood glucose progression to diabetes after intervention
reduce incidence of blood glucose progression
Time frame: Day 0, Week12，Week 24
Hemoglobin A1C、Glycated Albumin
Changes of Hemoglobin A1C and Glycated Albumin.
Time frame: Day 0, Week 24
The levels of serum insulin
Insulin levels were measured on an empty stomach, 30 minutes, 60 minutes and 120 minutes after oral administration of 75 g of glucose.
Time frame: Day 0, Week 24
The levels of serum C-peptid
C-peptide levels were measured on an empty stomach, 30 minutes, 60 minutes and 120 minutes after oral administration of 75 g of glucose.
Time frame: Day 0, Week 24
Body weight
Changes of body weight.
Time frame: Day 0, Week12，Week 24
No study locations are listed for this record.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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