Clinical trial NCT03330184: Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level
Official title: Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Berberine Hydrochloride
Keywords: Bifidobacterium
People With Abnormal Glucose Level
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
Collaborators: name: Second Affiliated Hospital of Xi'an Jiaotong University
name: Yan'an University Affiliated Hospital
name: Shaanxi Aerospace Hospital
name: Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd
name: Xi'an Gaoxin Hospital
name: Chang'An Hospital
name: Xi'an Central Hospital
name: Yan'an people's Hospital
name: Shangluo Central Hospital
First posted: 2017-11-06
Enrollment: 300
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 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.

Eligibility criteria: Inclusion Criteria:

* Informed consent obtained before any trial-related activities.
* Male or female between 18 and 70 years of old.
* 19≤Body mass index(BMI)≤30kg/m\^2.
* No participate in any clinical trial at least 3 months.
* Diagnosed impaired fasting glucose(IFG) and impaired glucose tolerance(IGT) or Diabetes.
* In visit 1, 5.60mmol/L≤Fasting plasma glucose(FPG)\<8.0mmol/L; in visit 2, 6.1≤FPG\<8.0mmol/L or 7.8≤2-hour postprandial plasma glucose(2h-PPG) \<17mmol/L.
* Females in child-bearing period should be given birth control.
* No severe disease about heart, lung and kidney.

Exclusion Criteria:

* Type 1 diabetes
* Diabetes patients with previously treated or untreated FPG ≥ 8 mmol/L or 2-h PPG ≥ 17 mmol/L;
* Women of childbearing potential who are pregnant, breastfeeding or intend to become pregnant or are not using adequate contraceptive methods.
* Those who are allergic to study drugs
* Unable to cooperate
* Abnormal liver function, ALT and AST are more than 2 times of the normal upper limit
* Renal injury, blood creatinine ≥133 µmol/L
* Poor blood pressure control, systolic blood pressure SBP≥160mmHg and/or diastolic blood pressure DBP≥95mmHg
* Patients with chronic gastrointestinal diseases (pancreatitis, inflammatory bowel disease) and history of intestinal surgery
* Patients with severe heart disease, such as heart failure, unstable angina pectoris, acute myocardial infarction
* Chronic hypoxic diseases such as emphysema, pulmonary heart disease
* Having obvious diseases of the blood system
* Persons with tumor diseases
* Endocrine diseases, such as hyperthyroidism and hypercortisolism
* Mental illness, abuse of alcohol, drugs or other substances
* Persons with long-term oral or intravenous corticosteroid hormones therapy
* Having stress conditions such as surgery, severe trauma, etc.

Primary outcomes:
measure: Change of absolute value of fasting plasma glucose (mmol/L)
timeFrame: baseline and week 16
Secondary outcomes:
measure: Change of absolute value of 2-hour postprandial plasma glucose (mmol/L)
timeFrame: baseline and week 16
measure: Change of level of HbA1c (%)
timeFrame: baseline and week 16
measure: Change of level of systolic pressure (mmHg)
timeFrame: baseline and week 16
measure: Change of level of diastolic pressure (mmHg)
timeFrame: baseline and week 16
measure: Change of level of serum total cholesterol (mmol/L)
timeFrame: baseline and week 16
measure: Change of level of low-density lipoprotein cholesterol (mmol/L)
timeFrame: baseline and week 16
measure: Change of level of high-density lipoprotein cholesterol (mmol/L)
timeFrame: baseline and week 16
measure: Change of level of triglycerides (mmol/L)
timeFrame: baseline and week 16
measure: Change of absolute value of body weight (kg)
timeFrame: baseline and week 16
measure: Change of absolute value of body mass index (BMI) (kg/m^2)
timeFrame: baseline and week 16
measure: Change of level of homeostasis model assessment (HOMA) index
timeFrame: baseline and week 16
measure: Change of level of insulin early-phase secretion index
timeFrame: baseline and week 16
measure: Change of level of insulin late-phase secretion index
timeFrame: baseline and week 16
measure: Change of level of GLP-1(pmol/L)
timeFrame: baseline and week 16
measure: Change of abundances of gut microbiota (%)
timeFrame: baseline and week 16
Other outcomes:
Locations:
Study officials:
affiliation: Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University
name: Qiuhe Ph.D. Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ming J, Yu X, Xu X, Wang L, Ding C, Wang Z, Xie X, Li S, Yang W, Luo S, He Q, Du Y, Tian Z, Gao X, Ma K, Fang Y, Li C, Zhao J, Wang X, Ji Q. Effectiveness and safety of Bifidobacterium and berberine in human hyperglycemia and their regulatory effect on the gut microbiota: a multi-center, double-blind, randomized, parallel-controlled study. Genome Med. 2021 Aug 9;13(1):125. doi: 10.1186/s13073-021-00942-7.
citation: Ming J, Xu S, Liu C, Liu X, Jia A, Ji Q. Effectiveness and safety of bifidobacteria and berberine in people with hyperglycemia: study protocol for a randomized controlled trial. Trials. 2018 Jan 26;19(1):72. doi: 10.1186/s13063-018-2438-5.