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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330184
Recruitment Status : Completed
First Posted : November 6, 2017
Last Update Posted : March 15, 2021
Sponsor:
Collaborators:
Second Affiliated Hospital of Xi'an Jiaotong University
Yan'an University Affiliated Hospital
Shaanxi Aerospace Hospital
Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd
Xi'an Gaoxin Hospital
Chang'An Hospital
Xi'an Central Hospital
Yan'an people's Hospital
Shangluo Central Hospital
Information provided by (Responsible Party):
Xijing Hospital

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.

Condition or disease Intervention/treatment Phase
Berberine Hydrochloride Drug: Berberine Hydrochloride group Drug: Bifidobacterium group Drug: Berberine Hydrochloride and Bifidobacterium group Drug: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.
Actual Study Start Date : October 2015
Actual Primary Completion Date : April 2018
Actual Study Completion Date : April 2018

Arm Intervention/treatment
Experimental: Berberine Hydrochloride group
2/day, 16 weeks
Drug: Berberine Hydrochloride group
Experimental: Bifidobacterium group
2/day, 16 weeks
Drug: Bifidobacterium group
Experimental: Berberine Hydrochloride and Bifidobacterium group
2/day, 16 weeks
Drug: Berberine Hydrochloride and Bifidobacterium group
Placebo Comparator: placebo
bifidobacterium mimetic capsules berberine mimetic tablets,2/day, 16 weeks
Drug: placebo



Primary Outcome Measures :
  1. Change of absolute value of fasting plasma glucose (mmol/L) [ Time Frame: baseline and week 16 ]
    Fasting plasma glucose will be measured during oral glucose tolerance test (OGTT) by glucose oxidase method at baseline and week 16.


Secondary Outcome Measures :
  1. Change of absolute value of 2-hour postprandial plasma glucose (mmol/L) [ Time Frame: baseline and week 16 ]
    2-hour postprandial plasma glucose will be measured during OGTT by glucose oxidase method at baseline and week 16.

  2. Change of level of HbA1c (%) [ Time Frame: baseline and week 16 ]
    HbA1c will be tested in plasma by high-performance liquid chromatography at baseline and week 16.

  3. Change of level of systolic pressure (mmHg) [ Time Frame: baseline and week 16 ]
    Systolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.

  4. Change of level of diastolic pressure (mmHg) [ Time Frame: baseline and week 16 ]
    Diastolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.

  5. Change of level of serum total cholesterol (mmol/L) [ Time Frame: baseline and week 16 ]
    Serum total cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.

  6. Change of level of low-density lipoprotein cholesterol (mmol/L) [ Time Frame: baseline and week 16 ]
    Serum low-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.

  7. Change of level of high-density lipoprotein cholesterol (mmol/L) [ Time Frame: baseline and week 16 ]
    Serum high-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.

  8. Change of level of triglycerides (mmol/L) [ Time Frame: baseline and week 16 ]
    Serum triglycerides will be measured by fully automatic biochemical analyser at baseline and week 16.

  9. Change of absolute value of body weight (kg) [ Time Frame: baseline and week 16 ]
    Body weight will be measured by weighing scale using the standard methods at baseline and week 16.

  10. Change of absolute value of body mass index (BMI) (kg/m^2) [ Time Frame: baseline and week 16 ]
    Weight and height will be combined to report BMI in kg/m^2 at baseline and week 16.

  11. Change of level of homeostasis model assessment (HOMA) index [ Time Frame: baseline and week 16 ]
    Fasting serum insulin and fasting plasma glucose will be calculated for HOMA index at baseline and week 16.

  12. Change of level of insulin early-phase secretion index [ Time Frame: baseline and week 16 ]
    Fasting serum insulin and 30 min post serum insulin during OGTT will be calculated for early-phase secretion index at baseline and week 16 .

  13. Change of level of insulin late-phase secretion index [ Time Frame: baseline and week 16 ]
    Fasting serum insulin and 2-hour post serum insulin during OGTT will be calculated for late-phase secretion index at baseline and week 16 .

  14. Change of level of GLP-1(pmol/L) [ Time Frame: baseline and week 16 ]
    GLP-1 will be measured in serum by ELISA KIT at baseline and week 16.

  15. Change of abundances of gut microbiota (%) [ Time Frame: baseline and week 16 ]
    Fecal samples will be measured by metagenomic sequencing to obtain abundances of gut microbiota at baseline and week 16.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330184


Sponsors and Collaborators
Xijing Hospital
Second Affiliated Hospital of Xi'an Jiaotong University
Yan'an University Affiliated Hospital
Shaanxi Aerospace Hospital
Genertec Universal Xi'an Aero-Engine hospital (Xi' an) Co., Ltd
Xi'an Gaoxin Hospital
Chang'An Hospital
Xi'an Central Hospital
Yan'an people's Hospital
Shangluo Central Hospital
Investigators
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Principal Investigator: Qiuhe Ph.D. Ji, M.D. Department of Endocrinology,Xi jing Hospital,Fourth Military Medical University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT03330184    
Other Study ID Numbers: 2013KTZB
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: March 15, 2021
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xijing Hospital:
Bifidobacterium
People With Abnormal Glucose Level