Effects of Berberine Hydrochloride and Bifidobacterium in Prediabetes Prevention and Treatment

NCT ID: NCT02082756

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-04-30

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.

Conditions

Prediabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Bifidobacterium viable pharmaceutics

Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks

Group Type: EXPERIMENTAL

Bifidobacterium viable pharmaceutics

Intervention Type: DRUG

Berberine Hydrochloride

Berberine Hydrochloride, 0.5g, 2/day, 12 weeks

Group Type: EXPERIMENTAL

Berberine Hydrochloride

Intervention Type: DRUG

lifestyle counseling

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bifidobacterium viable pharmaceutics

Intervention Type: DRUG

Berberine Hydrochloride

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qiu Ji, Ph.D..M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Endocrinology, Xijing Hospital, Fourth Military Medical University

Locations

Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The 323rd Hospital of People's Liberation Army

Xi'an, Shaanxi, China

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Countries

China

Other Identifiers

2013KTZB03-02-01B

Identifier Type: -

Identifier Source: org_study_id