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

Primary Purpose

Prediabetes

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

NIUCHANG

Placebo

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring Inulin, Soluble dietary fiber, Prediabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test group

Control group

Arm Description

NIUCHANG（Soluble dietary fiber + prebiotics）：Oral, 1 bag (15g) once a day, taking 24 weeks

Placebo（inactive drug ingredient）：Oral, 1 bag (15g) once a day, taking 24 weeks

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in insulin resistance index

the incidence of blood sugar reversion to normal was main observed

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.

Incidence of blood glucose stabilization in pre-diabetes after intervention

blood glucose becomes stable

Incidence of blood glucose progression to diabetes after intervention

reduce incidence of blood glucose progression

Hemoglobin A1C、Glycated Albumin

Changes of Hemoglobin A1C and Glycated Albumin.

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.

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.

Body weight

Changes of body weight.

Full Information

NCT ID

NCT03794232

First Posted

January 3, 2019

Last Updated

January 3, 2019

Sponsor

Inuling (Bei Jing) Science and Technology Co. Ltd

Collaborators

Peking Union Medical College Hospital, Proswell Medical Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03794232

Brief Title

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

Official Title

Study on the Mechanisms of Soluble Dietary Fiber Extracted From Jerusalem Artichoke in the Treatment of Pre-type 2 Diabetes

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

May 30, 2016 (Actual)

Primary Completion Date

April 4, 2018 (Actual)

Study Completion Date

April 4, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Inuling (Bei Jing) Science and Technology Co. Ltd

Collaborators

Peking Union Medical College Hospital, Proswell Medical Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prediabetes

Keywords

Inulin, Soluble dietary fiber, Prediabetes

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

246 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test group

Arm Type

Experimental

Arm Description

NIUCHANG（Soluble dietary fiber + prebiotics）：Oral, 1 bag (15g) once a day, taking 24 weeks

Arm Title

Control group

Arm Type

Placebo Comparator

Arm Description

Placebo（inactive drug ingredient）：Oral, 1 bag (15g) once a day, taking 24 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

NIUCHANG

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Incidence of blood sugar reversal to normal after intervention

Description

Time Frame

Day 0, Week 24

Secondary Outcome Measure Information:

Title

Changes in insulin resistance index

Description

the incidence of blood sugar reversion to normal was main observed

Time Frame

Day 0, Week 24

Title

Changes in intestinal flora

Description

Time Frame

Day 0, Week1，Week4，Week12，Week 24

Title

Incidence of blood glucose stabilization in pre-diabetes after intervention

Description

blood glucose becomes stable

Time Frame

Day 0, Week12，Week 24

Title

Incidence of blood glucose progression to diabetes after intervention

Description

reduce incidence of blood glucose progression

Time Frame

Day 0, Week12，Week 24

Title

Hemoglobin A1C、Glycated Albumin

Description

Changes of Hemoglobin A1C and Glycated Albumin.

Time Frame

Day 0, Week 24

Title

The levels of serum insulin

Description

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

Title

The levels of serum C-peptid

Description

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

Title

Body weight

Description

Changes of body weight.

Time Frame

Day 0, Week12，Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

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

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