Effect of Inulin-type Fructose Extracted From Jerusalem Artichoke on Improving Prediabetic State of Type 2 Diabetes

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 At the end of one course of treatment, if the blood glucose progresses to the stage of diabetes, the test is withdrawn and treated according to clinical routine.

Inclusion criteria

The following various situations need to be met at the same time in order to be selected:

• According to the diagnostic criteria for impaired glucose tolerance in the WHO Diabetes Diagnosis and Classification Standard in 1999: fasting blood glucose ≥6.1mmol/L and <7.0mmol/L, blood glucose 2 hours after oral administration of 75g glucose ≥7.8mmol/L and < 11.1mmol/L;
• BMI：20kg/㎡ ≤ BMI ≤ 35kg/㎡；
• Age ≥ 18 and ≤ 70 years old, gender is not limited;
• Voluntarily participate in the trial and sign the informed consent form.

Exclusion criteria

Any of the following circumstances should be excluded and cannot be selected:

• Acute cardiovascular and cerebrovascular events or myocardial infarction within 6 months;
• Laboratory examination: liver function AST or ALT ≥ 2.5 × ULN; renal function Cr > 1.2 × ULN;
• Those with severe gastrointestinal diseases, such as active peptic ulcer, intestinal obstruction, etc.; those who have changed the history of normal structure of the gastrointestinal tract;
• Hypertensive patients with poor blood pressure control (blood pressure SBP ≥ 160 mmHg and / or DBP ≥ 100 mmHg);
• Those with severe blood system diseases;
• Those with other endocrine system diseases, such as hyperthyroidism or hypercortisolism;
• Those who have a stress state or have secondary blood glucose elevation factors (such as those who take glucocorticoids);
• Women who are pregnant or breast-feeding, who are planning to be pregnant or who are not willing to contraception during the study;
• Drug or other drug abusers;
• Those who may be allergic to the test drug;
• Those who have participated in other drug trials within 3 months;
• Those who are unable to cooperate with mental illness;
• Other circumstances The investigator believes that it is not suitable for the group.