Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level

NCT03330184 | Completed DMC

• 1 other identifier: 2013KTZB
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Berberine Hydrochloride

Keywords

Bifidobacterium; People With Abnormal Glucose Level

Outcome Measures

Primary Outcomes (1)

• Change of absolute value of fasting plasma glucose (mmol/L)

  Fasting plasma glucose will be measured during oral glucose tolerance test (OGTT) by glucose oxidase method at baseline and week 16.

  baseline and week 16

Secondary Outcomes (15)

• Change of absolute value of 2-hour postprandial plasma glucose (mmol/L)

  baseline and week 16

• Change of level of HbA1c (%)

  baseline and week 16

• Change of level of systolic pressure (mmHg)

  baseline and week 16

• Change of level of diastolic pressure (mmHg)

  baseline and week 16

• Change of level of serum total cholesterol (mmol/L)

  baseline and week 16

Study Arms (4)

Berberine Hydrochloride group

EXPERIMENTAL

2/day, 16 weeks

Drug: Berberine Hydrochloride group

Bifidobacterium group

EXPERIMENTAL

2/day, 16 weeks

Drug: Bifidobacterium group

Berberine Hydrochloride and Bifidobacterium group

EXPERIMENTAL

2/day, 16 weeks

Drug: Berberine Hydrochloride and Bifidobacterium group

placebo

PLACEBO COMPARATOR

bifidobacterium mimetic capsules berberine mimetic tablets,2/day, 16 weeks

Drug: placebo

Interventions

Berberine Hydrochloride group DRUG

Berberine Hydrochloride group

Bifidobacterium group DRUG

Bifidobacterium group

Berberine Hydrochloride and Bifidobacterium group DRUG

Berberine Hydrochloride and Bifidobacterium group

placebo DRUG

placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent obtained before any trial-related activities.
• Male or female between 18 and 70 years of old.
• ≤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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead
• Second Affiliated Hospital of Xi'an Jiaotong University: collaborator
• Yan'an University Affiliated Hospital: collaborator
• Shaanxi Aerospace Hospital: collaborator
• Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd: collaborator
• Xi'an Gaoxin Hospital: collaborator
• Chang'An Hospital: collaborator
• Xi'an Central Hospital: collaborator
• Yan'an people's Hospital: collaborator
• Shangluo Central Hospital: collaborator

Related Publications (2)

• 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.

  PMID: 34365978 DERIVED

• 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.

  PMID: 29373989 DERIVED

Study Officials

• Qiuhe Ph.D. Ji, M.D.

  Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2017
• First Posted: November 6, 2017
• Study Start: October 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: March 15, 2021

Record last verified: 2018-11