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

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ClinicalTrials.gov Identifier: NCT03330184
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : November 12, 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

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.

Condition or disease Intervention/treatment Phase
Berberine Hydrochloride Drug: Berberine Hydrochloride group Drug: Bifidobacterium group Drug: Berberine Hydrochloride and Bifidobacterium group Drug: placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.
Actual Study Start Date : October 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)

  2. 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



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330184


Locations
China, Shaanxi
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an,, Shaanxi, China, 710061
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710004
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, China, 710068
Sponsors and Collaborators
Xijing Hospital
First Affiliated Hospital Xi'an Jiaotong University
Second Affiliated Hospital of Xi'an Jiaotong University
Shaanxi Provincial People's Hospital
Investigators
Principal Investigator: Qiuhe Ph.D. Ji, M.D. Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03330184     History of Changes
Other Study ID Numbers: 2013KTZB
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 12, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Xijing Hospital:
Bifidobacterium
People With Abnormal Glucose Level