Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02084004
• Other study ID #: 2013KTZB03-02-01A
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: November 2015
• Est. completion date: April 2018

Study information

• Verified date: November 2018
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the beneficial effects of Bifidobacterium Hydrochloride and Berberine on lowering glucose in patients with type 2 diabetes mellitus and to detect the potential mechanism.

Description:

Gut microbiota maybe play an important role in patients with type 2 diabetes mellitus (T2DM). 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 Hydrochloride and Berberine on lowering glucose in patients with T2DM and to detect the potential mechanism.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

• Newly diagnosed T2DM (OGTT) or not received previous pharmacological treatment

• 7%=HbA1c=9%

• 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 or 1 diabetes mellitus received previous pharmacological treatment

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Bifidobacterium viable pharmaceutics

• Berberine Hydrochloride

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	Shaanxi Provincial People's Hospital	Xi'an	Shaanxi
China	The 323rd Hospital of People's Liberation Army	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline to week 12	Change was measured at baseline and week 12 after randomization. Change was reported as the absolute difference in % HbA1c.	Baseline and week 12
Secondary	Percentage of subjects achieving HbA1c < 7% at week 12		Week 12
Secondary	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
Secondary	Changes in postprandial glucagon-like peptide-1 (GLP-1) secretion between baseline and week 12	Plasma level of GLP-1 at baseline and week 12 during a 2 hour-meal test.	Baseline and week 12
Secondary	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