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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330184
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 13, 2018
Sponsor:
Collaborators:
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Information provided by (Responsible Party):
Xijing Hospital

Tracking Information
First Submitted Date  ICMJE October 18, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date November 13, 2018
Actual Study Start Date  ICMJE October 2015
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
Change in fasting blood glucose between baseline to week 16 [ Time Frame: baseline and week 16 ]
fasting blood glucose are measured at baseline and week 16
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • Change in 2-hour postprandial blood glucose between baseline to week 16 [ Time Frame: baseline and week 16 ]
    2-hour postprandial blood glucose are measured at baseline and week 16 during Oral Glucose Tolerance Test(OGTT)
  • Gut microbiome composition [ Time Frame: baseline and week 16 ]
    faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level
Official Title  ICMJE Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Berberine Hydrochloride
Intervention  ICMJE
  • Drug: Berberine Hydrochloride group
  • Drug: Bifidobacterium group
  • Drug: Berberine Hydrochloride and Bifidobacterium group
  • Drug: placebo
Study Arms  ICMJE
  • Experimental: Berberine Hydrochloride group
    2/day, 16 weeks
    Intervention: Drug: Berberine Hydrochloride group
  • Experimental: Bifidobacterium group
    2/day, 16 weeks
    Intervention: Drug: Bifidobacterium group
  • Experimental: Berberine Hydrochloride and Bifidobacterium group
    2/day, 16 weeks
    Intervention: Drug: Berberine Hydrochloride and Bifidobacterium group
  • Placebo Comparator: placebo
    bifidobacterium mimetic capsules berberine mimetic tablets,2/day, 16 weeks
    Intervention: Drug: placebo
Publications * Ming J, Xu S, Liu C, Liu X, Jia A, Ji Q. Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):72. doi: 10.1186/s13063-018-2438-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 30, 2017)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2018
Actual Primary Completion Date April 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
  • Diagnosed impaired fasting glucose(IFG) and impaired glucose tolerance(IGT) or Diabetes.
  • In visit 1, 5.60mmol/L≤Fasting blood glucose(FBG)<8.0mmol/L; in visit 2, 6.1≤FPG<8.0mmol/L or 7.8≤2-hour postprandial blood glucose(2h-PPG) <17mmol/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 1 diabetes mellitus.
  • Diabetes patients with already be treated or not be treated but FBG ≥8mmol/L or 2h-PPG ≥ 17mmol/L.
  • 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 .
  • 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.
  • Known or suspected hypersensitivity to trial products or related products.
  • Known or suspected abuse of alcohol, narcotics or illicit drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330184
Other Study ID Numbers  ICMJE 2013KTZB
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Xijing Hospital
Study Sponsor  ICMJE Xijing Hospital
Collaborators  ICMJE
  • First Affiliated Hospital Xi'an Jiaotong University
  • Second Affiliated Hospital of Xi'an Jiaotong University
  • Shaanxi Provincial People's Hospital
Investigators  ICMJE
Principal Investigator: Qiuhe Ph.D. Ji, M.D. Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University
PRS Account Xijing Hospital
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP