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Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

Primary Purpose

Prediabetes

Status
Withdrawn
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Bifidobacterium viable pharmaceutics
Berberine Hydrochloride
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prediabetes focused on measuring Prediabetes, Berberine Hydrochloride, Bifidobacterium

Eligibility Criteria

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

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities
  • Male or female between 18 and 70 years of age
  • 19≤Body mass index(BMI)≤30kg/m2
  • No participate in any clinical trial at least 3 months
  • Fasting blood glucose(FBG)<7.0mmol/L and 2-hour postprandial blood glucose(2hPBG)<11.1mmol/L
  • Females in child-bearing period should be given birth control
  • No severe disease about heart, lung and kidney
  • Ability and willingness to adhere to the protocol including performance of self-monitored blood glucose (SMBG) profiles according to the protocol;
  • Subject is likely to comply with the Investigators instruction.

Exclusion Criteria:

  • Type 2 diabetes mellitus or type 1 diabetes mellitus
  • Females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods
  • Impaired liver function, defined as Aspartate aminotransferase(AST) or Alanine transaminase(ALT)> 2 times upper limit of normal (central laboratory)
  • Impaired renal function, defined as serum-creatinine≥133μmol/L
  • Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg and /or diastolic blood pressure≥95mmHg)
  • Chronic gastrointestinal diseases
  • Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer)
  • Any clinically significant disease or disorder, which in the Investigator's opinion could interfere with the results of the trial
  • Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read and write
  • Previous participation in this trial. Participation is defined as randomized. Re-screening of screening failures is allowed only once within the limits of the recruitment period
  • Known or suspected hypersensitivity to trial products or related products
  • Known or suspected abuse of alcohol, narcotics or illicit drugs.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong University
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • The 323rd Hospital of People's Liberation Army
  • Shaanxi Provincial People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Bifidobacterium viable pharmaceutics

Berberine Hydrochloride

lifestyle counseling

Arm Description

Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks

Berberine Hydrochloride, 0.5g, 2/day, 12 weeks

Outcomes

Primary Outcome Measures

Change in 2-hour postprandial blood glucose between baseline to week 12
2-hour postprandial blood glucose are measured at baseline and week 12 during a 2 hour-meal test.

Secondary Outcome Measures

Gut microbiome composition
Faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces.
Adverse effects
Standardized questionaries regarding gastrointestinal function are filled out at each study visit (0, 4, 8 and 12 weeks after randomization) to detect possible adverse effects of antibiotics. In addition, subjects are given a calendar and informed to write down any symptom or illness during the study period.

Full Information

First Posted
March 6, 2014
Last Updated
November 11, 2018
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02082756
Brief Title
Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment
Official Title
Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment：an Open-label, Multicenter，Randomized, Prospective，Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Withdrawn
Why Stopped
The sponsor have not enough money to support this trial
Study Start Date
November 2015 (Anticipated)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetes
Keywords
Prediabetes, Berberine Hydrochloride, Bifidobacterium

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bifidobacterium viable pharmaceutics
Arm Type
Experimental
Arm Description
Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks
Arm Title
Berberine Hydrochloride
Arm Type
Experimental
Arm Description
Berberine Hydrochloride, 0.5g, 2/day, 12 weeks
Arm Title
lifestyle counseling
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Bifidobacterium viable pharmaceutics
Intervention Type
Drug
Intervention Name(s)
Berberine Hydrochloride
Primary Outcome Measure Information:
Title
Change in 2-hour postprandial blood glucose between baseline to week 12
Description
2-hour postprandial blood glucose are measured at baseline and week 12 during a 2 hour-meal test.
Time Frame
Baseline and Week 12
Secondary Outcome Measure Information:
Title
Gut microbiome composition
Description
Faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces.
Time Frame
Baseline and week 12
Title
Adverse effects
Description
Standardized questionaries regarding gastrointestinal function are filled out at each study visit (0, 4, 8 and 12 weeks after randomization) to detect possible adverse effects of antibiotics. In addition, subjects are given a calendar and informed to write down any symptom or illness during the study period.
Time Frame
From baseline to week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent obtained before any trial-related activities Male or female between 18 and 70 years of age 19≤Body mass index(BMI)≤30kg/m2 No participate in any clinical trial at least 3 months Fasting blood glucose(FBG)<7.0mmol/L and 2-hour postprandial blood glucose(2hPBG)<11.1mmol/L Females in child-bearing period should be given birth control No severe disease about heart, lung and kidney Ability and willingness to adhere to the protocol including performance of self-monitored blood glucose (SMBG) profiles according to the protocol; Subject is likely to comply with the Investigators instruction. Exclusion Criteria: Type 2 diabetes mellitus or type 1 diabetes mellitus Females of childbearing potential who are pregnant，breastfeeding or intend to become pregnant or are not using adequate contraceptive methods Impaired liver function, defined as Aspartate aminotransferase(AST) or Alanine transaminase(ALT)> 2 times upper limit of normal (central laboratory) Impaired renal function, defined as serum-creatinine≥133μmol/L Uncontrolled treated/untreated severe hypertension (systolic blood pressure≥160mmHg and /or diastolic blood pressure≥95mmHg) Chronic gastrointestinal diseases Cancer and medical history of cancer (except basal cell skin cancer or squamous cell skin cancer) Any clinically significant disease or disorder, which in the Investigator's opinion could interfere with the results of the trial Mental incapacity, psychiatric disorder, unwillingness or language barriers precluding adequate understanding or co-operation, including subjects not able to read and write Previous participation in this trial. Participation is defined as randomized. Re-screening of screening failures is allowed only once within the limits of the recruitment period Known or suspected hypersensitivity to trial products or related products Known or suspected abuse of alcohol, narcotics or illicit drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Qiu Ji, Ph.D..M.D.
Organizational Affiliation
Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an,
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Facility Name
Second Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Name
The 323rd Hospital of People's Liberation Army
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710054
Country
China
Facility Name
Shaanxi Provincial People's Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710068
Country
China

12. IPD Sharing Statement

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Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

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