Status:
COMPLETED
Effect of Inulin-type Fructose Extracted From Jerusalem Artichoke on Improving Prediabetic State of Type 2 Diabetes
Lead Sponsor:
Inuling (Bei Jing) Science and Technology Co. Ltd
Collaborating Sponsors:
Peking Union Medical College Hospital
Proswell Medical Corporation
Conditions:
Prediabetes
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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 tr...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 30 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 4 2018
Estimated Enrollment :
246 Patients enrolled
Trial Details
Trial ID
NCT03794232
Start Date
May 30 2016
End Date
April 4 2018
Last Update
January 7 2019
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