Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level

March 10, 2021 updated by: Xijing Hospital

Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.

The aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gut microbiota may play an important role in patients with prediabetes. Berberine, which is usually used as an antibiotic drug, has been reported a potential glucose-lowering effect in vitro and in vivo studies. Bifidobacterium, as a familiar probiotics, can modulate gut microbiota and improve glucose and lipid metabolism in animal experiments. Therefore, the aim of this study is to assess the beneficial effects of Bifidobacterium and Berberine Hydrochloride on lowering glucose and delaying progress to diabetes in patients with prediabetes and to detect the potential mechanism.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities.
  • Male or female between 18 and 70 years of old.
  • 19≤Body mass index(BMI)≤30kg/m^2.
  • No participate in any clinical trial at least 3 months.
  • Diagnosed impaired fasting glucose(IFG) and impaired glucose tolerance(IGT) or Diabetes.
  • In visit 1, 5.60mmol/L≤Fasting plasma glucose(FPG)<8.0mmol/L; in visit 2, 6.1≤FPG<8.0mmol/L or 7.8≤2-hour postprandial plasma glucose(2h-PPG) <17mmol/L.
  • Females in child-bearing period should be given birth control.
  • No severe disease about heart, lung and kidney.

Exclusion Criteria:

  • Type 1 diabetes
  • Diabetes patients with previously treated or untreated FPG ≥ 8 mmol/L or 2-h PPG ≥ 17 mmol/L;
  • Women of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods.
  • Those who are allergic to study drugs
  • Unable to cooperate
  • Abnormal liver function, ALT and AST are more than 2 times of the normal upper limit
  • Renal injury, blood creatinine ≥133 µmol/L
  • Poor blood pressure control, systolic blood pressure SBP≥160mmHg and/or diastolic blood pressure DBP≥95mmHg
  • Patients with chronic gastrointestinal diseases (pancreatitis, inflammatory bowel disease) and history of intestinal surgery
  • Patients with severe heart disease, such as heart failure, unstable angina pectoris, acute myocardial infarction
  • Chronic hypoxic diseases such as emphysema, pulmonary heart disease
  • Having obvious diseases of the blood system
  • Persons with tumor diseases
  • Endocrine diseases, such as hyperthyroidism and hypercortisolism
  • Mental illness, abuse of alcohol, drugs or other substances
  • Persons with long-term oral or intravenous corticosteroid hormones therapy
  • Having stress conditions such as surgery, severe trauma, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Berberine Hydrochloride group
2/day, 16 weeks
Drug: Berberine Hydrochloride group
Experimental: Bifidobacterium group
2/day, 16 weeks
Drug: Bifidobacterium group
Experimental: Berberine Hydrochloride and Bifidobacterium group
2/day, 16 weeks
Drug: Berberine Hydrochloride and Bifidobacterium group
Placebo Comparator: placebo
bifidobacterium mimetic capsules berberine mimetic tablets,2/day, 16 weeks
Drug: placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of absolute value of fasting plasma glucose (mmol/L)
Time Frame: baseline and week 16
Fasting plasma glucose will be measured during oral glucose tolerance test (OGTT) by glucose oxidase method at baseline and week 16.
baseline and week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change of absolute value of 2-hour postprandial plasma glucose (mmol/L)
Time Frame: baseline and week 16
2-hour postprandial plasma glucose will be measured during OGTT by glucose oxidase method at baseline and week 16.
baseline and week 16
Change of level of HbA1c (%)
Time Frame: baseline and week 16
HbA1c will be tested in plasma by high-performance liquid chromatography at baseline and week 16.
baseline and week 16
Change of level of systolic pressure (mmHg)
Time Frame: baseline and week 16
Systolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.
baseline and week 16
Change of level of diastolic pressure (mmHg)
Time Frame: baseline and week 16
Diastolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.
baseline and week 16
Change of level of serum total cholesterol (mmol/L)
Time Frame: baseline and week 16
Serum total cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.
baseline and week 16
Change of level of low-density lipoprotein cholesterol (mmol/L)
Time Frame: baseline and week 16
Serum low-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.
baseline and week 16
Change of level of high-density lipoprotein cholesterol (mmol/L)
Time Frame: baseline and week 16
Serum high-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.
baseline and week 16
Change of level of triglycerides (mmol/L)
Time Frame: baseline and week 16
Serum triglycerides will be measured by fully automatic biochemical analyser at baseline and week 16.
baseline and week 16
Change of absolute value of body weight (kg)
Time Frame: baseline and week 16
Body weight will be measured by weighing scale using the standard methods at baseline and week 16.
baseline and week 16
Change of absolute value of body mass index (BMI) (kg/m^2)
Time Frame: baseline and week 16
Weight and height will be combined to report BMI in kg/m^2 at baseline and week 16.
baseline and week 16
Change of level of homeostasis model assessment (HOMA) index
Time Frame: baseline and week 16
Fasting serum insulin and fasting plasma glucose will be calculated for HOMA index at baseline and week 16.
baseline and week 16
Change of level of insulin early-phase secretion index
Time Frame: baseline and week 16
Fasting serum insulin and 30 min post serum insulin during OGTT will be calculated for early-phase secretion index at baseline and week 16 .
baseline and week 16
Change of level of insulin late-phase secretion index
Time Frame: baseline and week 16
Fasting serum insulin and 2-hour post serum insulin during OGTT will be calculated for late-phase secretion index at baseline and week 16 .
baseline and week 16
Change of level of GLP-1(pmol/L)
Time Frame: baseline and week 16
GLP-1 will be measured in serum by ELISA KIT at baseline and week 16.
baseline and week 16
Change of abundances of gut microbiota (%)
Time Frame: baseline and week 16
Fecal samples will be measured by metagenomic sequencing to obtain abundances of gut microbiota at baseline and week 16.
baseline and week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Xi'an Central Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
Shangluo Central Hospital
Yan'an University Affiliated Hospital
Xi'an Gaoxin Hospital
Shaanxi Aerospace Hospital
Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd
Chang'An Hospital
Yan'an People's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Qiuhe Ph.D. Ji, M.D., Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 18, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 6, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013KTZB

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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