Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment

November 11, 2018 updated by: Xijing Hospital

Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment：an Open-label, Multicenter，Randomized, Prospective，Controlled Study

The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the potential mechanism.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Gut microbiota maybe play an important role in patients with type 2 diabetes mellitus (T2DM). 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 Hydrochloride and Berberine on lowering glucose in patients with T2DM and to detect the potential mechanism.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • First Affiliated Hospital of Xi'an Jiaotong University
      • Xi'an, Shaanxi, China, 710004
        • Second Affiliated Hospital of Xi'an JiaoTong University
      • Xi'an, Shaanxi, China, 710054
        • The 323rd Hospital of People's Liberation Army
      • Xi'an, Shaanxi, China, 710068
        • Shaanxi Provincial People's Hospital

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

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 age
  • 19≤Body mass index(BMI)≤30kg/m2
  • No participate in any clinical trial at least 3 months
  • Newly diagnosed T2DM (OGTT) or not received previous pharmacological treatment
  • 7%≤HbA1c≤9%
  • 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 or 1 diabetes mellitus received previous pharmacological treatment
  • 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

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bifidobacterium viable pharmaceutics
Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks
Drug: Bifidobacterium viable pharmaceutics
Experimental: Berberine Hydrochloride
Berberine Hydrochloride, 0.5g, 2/day, 12 weeks
Drug: Berberine Hydrochloride
No Intervention: lifestyle counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c from baseline to week 12
Time Frame: Baseline and week 12
Change was measured at baseline and week 12 after randomization. Change was reported as the absolute difference in % HbA1c.
Baseline and week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of subjects achieving HbA1c < 7% at week 12
Time Frame: Week 12
Week 12
Gut microbiome composition
Time Frame: Baseline and week 12
Faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces.
Baseline and week 12
Changes in postprandial glucagon-like peptide-1 (GLP-1) secretion between baseline and week 12
Time Frame: Baseline and week 12
Plasma level of GLP-1 at baseline and week 12 during a 2 hour-meal test.
Baseline and week 12
Adverse effects
Time Frame: From baseline to week 12
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.
From baseline to week 12

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Qiuhe Ji, Ph.D.,M.D., Department of Endocrinology, Xijing Hospital, Fourth Military Medical University

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 (Anticipated)

November 1, 2015

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

February 27, 2014

First Submitted That Met QC Criteria

March 6, 2014

First Posted (Estimate)

March 11, 2014

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 11, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013KTZB03-02-01A

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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