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

NCT03794232 | Completed DMC

• 1 other identifier: S-749
• Study Type: interventional
• Target: 246
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Prediabetes

Keywords

Inulin; Soluble dietary fiber; Prediabetes

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 0, Week 24

Secondary Outcomes (8)

• Changes in insulin resistance index

  Day 0, Week 24

• Changes in intestinal flora

  Day 0, Week1，Week4，Week12，Week 24

• Incidence of blood glucose stabilization in pre-diabetes after intervention

  Day 0, Week12，Week 24

• Incidence of blood glucose progression to diabetes after intervention

  Day 0, Week12，Week 24

• Hemoglobin A1C、Glycated Albumin

  Day 0, Week 24

Study Arms (2)

Test group

EXPERIMENTAL

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

Dietary Supplement: NIUCHANG

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

NIUCHANG DIETARY_SUPPLEMENT

Test group

Placebo DIETARY_SUPPLEMENT

Control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inuling (Bei Jing) Science and Technology Co. Ltd: lead
• Peking Union Medical College Hospital: collaborator
• Proswell Medical Corporation: collaborator

MeSH Terms

Conditions

Prediabetic State

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 4, 2019
• Study Start: May 30, 2016
• Primary Completion: April 4, 2018
• Study Completion: April 4, 2018
• Last Updated: January 7, 2019

Record last verified: 2018-11