PrediabetesNCT03794232

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

A study testing NIUCHANG in people with Prediabetes, run by Inuling (Bei Jing) Science and Technology Co. Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Prediabetes
What is being tested?: NIUCHANG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 246 participants
Where: No sites listed yet
Study dates: 30 May 2016to 4 Apr 2018
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

About this study

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.

Read the 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.

Conditions: Prediabetes
Being tested: NIUCHANG, Placebo
Keywords: Inulin, Soluble dietary fiber, Prediabetes
Medical subject headings: Prediabetic State

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NIUCHANGDietary supplement
PlaceboDietary supplement

Study groups in NCT03794232
Study group	Role	What they receive
Test group	Experimental	NIUCHANG（Soluble dietary fiber + prebiotics）：Oral, 1 bag (15g) once a day, taking 24 weeks Receives: Dietary Supplement: NIUCHANG
Control group	Placebo comparator	Placebo（inactive drug ingredient）：Oral, 1 bag (15g) once a day, taking 24 weeks Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 0, Week 24

Secondary outcomes (8)

Changes in insulin resistance index
the incidence of blood sugar reversion to normal was main observed
Measured: 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.
Measured: Day 0, Week1，Week4，Week12，Week 24
Incidence of blood glucose stabilization in pre-diabetes after intervention
blood glucose becomes stable
Measured: Day 0, Week12，Week 24
Incidence of blood glucose progression to diabetes after intervention
reduce incidence of blood glucose progression
Measured: Day 0, Week12，Week 24
Hemoglobin A1C、Glycated Albumin
Changes of Hemoglobin A1C and Glycated Albumin.
Measured: 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.
Measured: 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.
Measured: Day 0, Week 24
Body weight
Changes of body weight.
Measured: Day 0, Week12，Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 May 20164 Apr 2018

First posted4 Jan 2019
Study start30 May 2016
Primary completion4 Apr 2018
Study completion4 Apr 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PrediabetesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 246 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03794232
Sponsor's protocol ID: S-749
Status last verified: Nov 2018
First submitted: 3 Jan 2019
Last updated: 7 Jan 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study on the Mechanisms of Soluble Dietary Fiber Extracted From Jerusalem Artichoke in the Treatment of Pre-type 2 Diabetes
ClinicalTrials.gov ID: NCT03794232
Acronym / sponsor ID: S-749
Conditions: Prediabetes
Keywords: Inulin, Soluble dietary fiber, Prediabetes
Study type: Interventional
Recruitment status: Completed
Enrolment: 246 participants (actual)
Lead sponsor: Inuling (Bei Jing) Science and Technology Co. LtdIndustry (pharma, biotech, devices)
Collaborators: Peking Union Medical College Hospital, Proswell Medical Corporation
Study start: 30 May 2016 (actual)
Primary completion: 4 Apr 2018 (actual)
Study completion: 4 Apr 2018 (actual)
First posted: 4 Jan 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Test group	Experimental	Dietary Supplement: NIUCHANGNIUCHANG（Soluble dietary fiber + prebiotics）：Oral, 1 bag (15g) once a day, taking 24 weeks
Control group	Placebo comparator	Dietary Supplement: PlaceboPlacebo（inactive drug ingredient）：Oral, 1 bag (15g) once a day, taking 24 weeks

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (14 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NIUCHANG	Dietary supplement	Test group
Placebo	Dietary supplement	Control group

Primary outcome

Incidence of blood sugar reversal to normal after intervention
Time frame: Day 0, Week 24
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.

8 secondary outcomes

Changes in insulin resistance index
Time frame: Day 0, Week 24
Changes in intestinal flora
Time frame: Day 0, Week1，Week4，Week12，Week 24
Incidence of blood glucose stabilization in pre-diabetes after intervention
Time frame: Day 0, Week12，Week 24
Incidence of blood glucose progression to diabetes after intervention
Time frame: Day 0, Week12，Week 24
Hemoglobin A1C、Glycated Albumin
Time frame: Day 0, Week 24
The levels of serum insulin
Time frame: Day 0, Week 24
The levels of serum C-peptid
Time frame: Day 0, Week 24
Body weight
Time frame: Day 0, Week12，Week 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2019.

Related trials for Prediabetes

Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
RecruitingPhase 3
A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity
Overweight, Prediabetic State
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
Recruiting
CGM-Enhanced DPP to Prevent Type 2 Diabetes in Adults With Prediabetes
PreDiabetes

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing NIUCHANG in people with Prediabetes, run by Inuling (Bei Jing) Science and Technology Co. Ltd.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of blood sugar reversal to normal after intervention (time frame: Day 0, Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03794232.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2019.