Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Xijing Hospital
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT02082756
First received: March 6, 2014
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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
Prediabetes
Drug: Bifidobacterium viable pharmaceutics
Drug: Berberine Hydrochloride
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082756

Contacts
Contact: Qiuhe Ji, Ph.D.,M.D. qiuheji@hotmail.com
Contact: Jie Ming, M.D. mingjie1207@163.com

Locations
China, Shaanxi
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.         
Shaanxi Provincial People's Hospital Not yet recruiting
Xi'an, Shaanxi, China, 710068
Contact: YangWei Wang, Ph.D.         
Principal Investigator: YangWei Wang, 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.         
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.         
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Qiu Ji, Ph.D..M.D. Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT02082756     History of Changes
Other Study ID Numbers: 2013KTZB03-02-01B
Study First Received: March 6, 2014
Last Updated: March 7, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Prediabetes
Berberine Hydrochloride
Bifidobacterium

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014