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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Bifidobacterium viable pharmaceutics
* Drug: Berberine Hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bifidobacterium viable pharmaceutics<br>Bifidobacterium viable pharmaceutics, 2 Capsules, 2/day, 12 weeks | Drug: Bifidobacterium viable pharmaceutics<br> <br> |
| Experimental: Berberine Hydrochloride<br>Berberine Hydrochloride, 0.5g, 2/day, 12 weeks | Drug: Berberine Hydrochloride<br> <br> |
| No Intervention: lifestyle counseling<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c < 7% at week 12 |  | Week 12 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes mellitus, Berberine Hydrochloride, Bifidobacterium