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Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by Xijing Hospital.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Xijing Hospital Identifier:
First received: March 6, 2014
Last updated: March 7, 2014
Last verified: March 2014
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.

Condition Intervention Phase
Drug: Bifidobacterium viable pharmaceutics
Drug: Berberine Hydrochloride
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment:an Open-label, Multicenter,Randomized, Prospective,Controlled Study

Resource links provided by NLM:

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • Change in 2-hour postprandial blood glucose between baseline to week 12 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and week 12 ]
    Faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces.

  • 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.

Estimated Enrollment: 400
Study Start Date: June 2014
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT02082756

Contact: Qiuhe Ji, Ph.D.,M.D.
Contact: Jie Ming, M.D.

China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an,, Shaanxi, China, 710061
Contact: BingYin Shi, Ph.D.         
Principal Investigator: BingYin Shi, M.D.         
Second Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710004
Contact: Xuan Xie, Ph.D.         
Principal Investigator: Xuan Xie, M.D.         
The 323rd Hospital of People's Liberation Army Not yet recruiting
Xi'an, Shaanxi, China, 710054
Contact: PeiJun Mao, Ph.D.         
Principal Investigator: PeiJun Mao, M.D.         
Shaanxi Provincial People's Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710068
Contact: YangWei Wang, Ph.D.         
Principal Investigator: YangWei Wang, M.D.         
Sponsors and Collaborators
Xijing Hospital
Principal Investigator: Qiu Ji, Ph.D..M.D. Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
  More Information

Responsible Party: Xijing Hospital Identifier: NCT02082756     History of Changes
Other Study ID Numbers: 2013KTZB03-02-01B
Study First Received: March 6, 2014
Last Updated: March 7, 2014

Keywords provided by Xijing Hospital:
Berberine Hydrochloride

Additional relevant MeSH terms:
Prediabetic State
Glucose Intolerance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia processed this record on April 28, 2017