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Berberine HydrochlorideNCT03330184

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

A study testing Berberine Hydrochloride group, Bifidobacterium group and Berberine Hydrochloride and Bifidobacterium group in people with Berberine Hydrochloride, run by Xijing Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Berberine Hydrochloride
What is being tested?
Berberine Hydrochloride group, Bifidobacterium group and Berberine Hydrochloride and Bifidobacterium group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
No sites listed yet
Study dates
Oct 2015to Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 17Show fewer
  • 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.

About this study

Official title: Effectiveness and Safety of Berberine Hydrochloride and Bifidobacterium in People With Abnormal Glucose Level: an Multicenter, Randomized, Double-blinded, Placebo-controlled Study.

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.

Read the 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.

Being tested
Berberine Hydrochloride group, Bifidobacterium group, Berberine Hydrochloride and Bifidobacterium group, placebo
Keywords
Bifidobacterium, People With Abnormal Glucose Level

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Berberine Hydrochloride groupDrug

  • Bifidobacterium groupDrug

  • Berberine Hydrochloride and Bifidobacterium groupDrug

  • placeboDrug

Study groups in NCT03330184
Study groupRoleWhat they receive
Berberine Hydrochloride groupExperimental2/day, 16 weeks
Receives: Drug: Berberine Hydrochloride group
Bifidobacterium groupExperimental2/day, 16 weeks
Receives: Drug: Bifidobacterium group
Berberine Hydrochloride and Bifidobacterium groupExperimental2/day, 16 weeks
Receives: Drug: Berberine Hydrochloride and Bifidobacterium group
placeboPlacebo comparatorbifidobacterium mimetic capsules berberine mimetic tablets,2/day, 16 weeks
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: baseline and week 16

Secondary outcomes (15)

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

    2-hour postprandial plasma glucose will be measured during OGTT by glucose oxidase method at baseline and week 16.

    Measured: baseline and week 16

  2. Change of level of HbA1c (%)

    HbA1c will be tested in plasma by high-performance liquid chromatography at baseline and week 16.

    Measured: baseline and week 16

  3. Change of level of systolic pressure (mmHg)

    Systolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.

    Measured: baseline and week 16

  4. Change of level of diastolic pressure (mmHg)

    Diastolic pressure will be measured by mercurial sphygmomanometer using the standard methods at baseline and week 16.

    Measured: baseline and week 16

  5. Change of level of serum total cholesterol (mmol/L)

    Serum total cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.

    Measured: baseline and week 16

  6. Change of level of low-density lipoprotein cholesterol (mmol/L)

    Serum low-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.

    Measured: baseline and week 16

  7. Change of level of high-density lipoprotein cholesterol (mmol/L)

    Serum high-density lipoprotein cholesterol will be measured by fully automatic biochemical analyser at baseline and week 16.

    Measured: baseline and week 16

  8. Change of level of triglycerides (mmol/L)

    Serum triglycerides will be measured by fully automatic biochemical analyser at baseline and week 16.

    Measured: baseline and week 16

  9. Change of absolute value of body weight (kg)

    Body weight will be measured by weighing scale using the standard methods at baseline and week 16.

    Measured: baseline and week 16

  10. Change of absolute value of body mass index (BMI) (kg/m^2)

    Weight and height will be combined to report BMI in kg/m^2 at baseline and week 16.

    Measured: baseline and week 16

  11. Change of level of homeostasis model assessment (HOMA) index

    Fasting serum insulin and fasting plasma glucose will be calculated for HOMA index at baseline and week 16.

    Measured: baseline and week 16

  12. Change of level of insulin early-phase secretion index

    Fasting serum insulin and 30 min post serum insulin during OGTT will be calculated for early-phase secretion index at baseline and week 16 .

    Measured: baseline and week 16

  13. Change of level of insulin late-phase secretion index

    Fasting serum insulin and 2-hour post serum insulin during OGTT will be calculated for late-phase secretion index at baseline and week 16 .

    Measured: baseline and week 16

  14. Change of level of GLP-1(pmol/L)

    GLP-1 will be measured in serum by ELISA KIT at baseline and week 16.

    Measured: baseline and week 16

  15. Change of abundances of gut microbiota (%)

    Fecal samples will be measured by metagenomic sequencing to obtain abundances of gut microbiota at baseline and week 16.

    Measured: baseline and week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2017
  2. Study startOct 2015
  3. Primary completionApr 2018
  4. Study completionApr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03330184
Sponsor's protocol ID
2013KTZB
Status last verified
Nov 2018
First submitted
18 Oct 2017
Last updated
15 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34365978

  • 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.

    PubMed 29373989

Questions about this trial

What is this clinical trial studying?

A study testing Berberine Hydrochloride group, Bifidobacterium group and Berberine Hydrochloride and Bifidobacterium group in people with Berberine Hydrochloride, run by Xijing Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of absolute value of fasting plasma glucose (mmol/L) (time frame: baseline and week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03330184, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2021.

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