Clinical trial NCT02084004: Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment
Official title: Effects of Berberine Hydrochloride and Bifidobacterium in Diabetes Mellitus Prevention and Treatment：an Open-label, Multicenter，Randomized, Prospective，Controlled Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes mellitus
Berberine Hydrochloride
Bifidobacterium
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2014-03-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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
* 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

Primary outcomes:
measure: Change in HbA1c from baseline to week 12
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Percentage of subjects achieving HbA1c < 7% at week 12
timeFrame: Week 12
measure: Gut microbiome composition
timeFrame: Baseline and week 12
measure: Changes in postprandial glucagon-like peptide-1 (GLP-1) secretion between baseline and week 12
timeFrame: Baseline and week 12
measure: Adverse effects
timeFrame: From baseline to week 12
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: The 323rd Hospital of People's Liberation Army
state: Shaanxi
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Xi'an
country: China
facility: Shaanxi Provincial People's Hospital
state: Shaanxi
Study officials:
affiliation: Department of Endocrinology, Xijing Hospital, Fourth Military Medical University
name: Qiuhe Ji, Ph.D.,M.D.
role: PRINCIPAL_INVESTIGATOR
References: