Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

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

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 Overview

• Status: Withdrawn
• Conditions: Prediabetes
• Intervention / Treatment: Drug: Bifidobacterium viable pharmaceutics; Drug: Berberine Hydrochloride

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
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • 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
    • Xi'an,, Shaanxi, China, 710061
      • First Affiliated Hospital of Xi'an Jiaotong University

Participation Criteria

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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

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 2-hour postprandial blood glucose between baseline to week 12	2-hour postprandial blood glucose are measured at baseline and week 12 during a 2 hour-meal test.	Baseline and Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome composition	Faecal bacterial composition determined from microbiological cultures and deep metagenomic next-generation sequencing of bacterial DNA in feces.	Baseline and week 12
Adverse effects	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

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

Study record dates

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: March 6, 2014
• First Submitted That Met QC Criteria: March 7, 2014
• First Posted (Estimate): March 10, 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: Prediabetes; Bifidobacterium; Berberine Hydrochloride
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 2013KTZB03-02-01B