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Type 2 DiabetesPhase 3NCT02861261

A Study on the Efficacy and Gut Microbiota of Berberine and Probiotics in Patients With Newly Diagnosed Type 2 Diabetes

A Phase 3 study testing 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes Read more about this study

Who is it for?
Ages 20 to 69 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteChina
Study dates
18 Aug 2016to May 2019
Phase
Phase 3
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 20 to 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Main Inclusion Criteria:

  1. Newly diagnosed type 2 diabetes defined as WHO (1999) diagnostic criteria ; Both Genders Eligible;
  2. Age: ≥20 and <70 years;
  3. BMI: 19.0 ~ 35.0kg/m2;
  4. Not receive previously with anti-diabetic agents (oral agents, GLP-1 or insulin);
  5. Have at least 2 months of life style intervention to control blood glucose before screening;
  6. HbA1c ≥6.5% and ≤10.0%, and fasting plasma glucose≥7.0 mmol/L and ≤13.3mmol/L at screening.

Details please see the study protocol. -

Main Exclusion Criteria:

  1. Significant impaired liver function (defined as alanine transaminase (ALT)> 2.5 times upper limit of normal); Impaired renal function (defined as serum-creatinine> 132μmol/L or eGFR <60 mL/min/1.73m2 ); Mental disease, severe infection, severe anemia, neutropenia disease;
  2. Other severe heart disease, such as congenital heart disease, rheumatic heart disease, hypertrophic or dilated cardiomyopathy, defined as New York Heart Association class III or IV;
  3. Allergic to gentamicin or other amino glycosides antibiotics;
  4. Histories of acute diabetic complications including diabetic ketoacidosis or hyperosmolar hyperglycemic non-ketotic coma within 3 months;
  5. Pregnancy;
  6. Acute and chronic diarrhea or severe constipation of the digestive tract diseases;
  7. Medical history of malignant tumor (except local skin basal cell carcinoma) in the past 5 years;
  8. Medical history of intestine, or other digestive tract surgery (such as cholecystectomy) within one year, or other non gastrointestinal surgery within 6 months.

Details please see the study protocol.

-

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin hospital,Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: Probiotics and BeRberine on the Efficacy and Change of Gut MicrObiota in paTients With Newly Diagnosed Type 2 diabEtes（PREMOTE Study）

The purpose of this study is to conduct a multicenter randomized, double-blind, placebo-controlled clinical trial, evaluating the effects and change of gut microbiota after berberine and/or probiotics administration in patients with newly diagnosed type 2 diabetes

Read the detailed description

In the present study, about 400 newly-diagnosed type 2 diabetes patients will be enrolled from multiple centers in China. Randomisation was computer generated and stratified by age. After screening, eligible subjects will be given Gentamycin Sulfate Sustained-release Tablets 80mg bid po for a week at the washout period, then all participants will be randomly assigned into one of the following four groups: Berberine hydrochloride tablets（0.6g bid po）and ProMetS probiotics powder（4g qN po), Berberine placebo tablets（6 pills bid po) and ProMetS probiotics powder (4g qN po), Berberine hydrochloride tablets（0.6g bid po）and Probiotics placebo powder (2 strips qN po), Berberine placebo tablets（6 pills bid po) and Probiotics placebo powder (2 strips qN po) for 3 months.

The primary objective is to determine whether a combination of probiotics and berberine is preferable to either berberine alone or probiotics alone, in comparison with placebo in improving 1). glycemic control, as measured by change in HbA1c level from baseline to 13-week follow-up, and 2). glycemic control, as measured by change in HbA1c level from baseline to 13-week follow-up in participants aged ≥ 50 years.

Blood, feces and urine samples will be collected before and after treatment. HbA1C, fasting plasma glucose (FPG), postprandial plasma glucose (PPG), GLP-1 , lipids, amino acids, bile acids and other metabolic related components and parameters will be measured. Furthermore, the change of gut microbiota will be evaluated too.

Conditions
Type 2 Diabetes
Being tested
1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder, 1. Berberine placebo tablets ; 2. ProMetS probiotics powder, 1. Berberine hydrochloride tablets; 2. Probiotics placebo powder, 1. Berberine placebo tablets; 2. Probiotics placebo powder
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powderDrug

    1. 0.6g (6 pills) of Berberine tablets administered twice a day orally before meal ;
    2. 4g (2 strips) of ProMetS probiotics powder administered orally every night

  • 1. Berberine placebo tablets ; 2. ProMetS probiotics powderDrug

    1. 6 pills of Berberine placebo tablets administered twice a day orally before meal;
    2. 4g (2 strips) of ProMetS probiotics powder administered orally every night

  • 1. Berberine hydrochloride tablets; 2. Probiotics placebo powderDrug

    1. 0.6g (6 pills) of Berberine tablets administered twice a day orally before meal;
    2. 2 strips of probiotics placebo powder administered orally every night

  • 1. Berberine placebo tablets; 2. Probiotics placebo powderDrug

    1. 6 pills of Berberine placebo tablets administered twice a day orally before meal;
    2. 2 strips of probiotics placebo powder administered orally every night
Study groups in NCT02861261
Study groupRoleWhat they receive
Group AExperimentalNot described
Receives: Drug: 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder
Group BExperimentalNot described
Receives: Drug: 1. Berberine placebo tablets ; 2. ProMetS probiotics powder
Group CExperimentalNot described
Receives: Drug: 1. Berberine hydrochloride tablets; 2. Probiotics placebo powder
Group DPlacebo comparatorNot described
Receives: Drug: 1. Berberine placebo tablets; 2. Probiotics placebo powder

What is being measured

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

  1. HbA1c

    Measured: 13 weeks

Secondary outcomes (12)

  1. Gut microbiome

    Measured: 13 weeks

  2. Fasting glucose levels

    Measured: 13 weeks

  3. 2-hour postprandial glucose levels

    Measured: 13 weeks

  4. Fasting insulin levels

    Measured: 13 weeks

  5. 2-hour postprandial insulin levels

    Measured: 13 weeks

  6. Serum Triglycerides

    Measured: 13 weeks

  7. Serum total Cholesterol

    Measured: 13 weeks

  8. Serum HDL-c

    Measured: 13 weeks

  9. Serum LDL-c

    Measured: 13 weeks

  10. Blood metabolomics profile measurement

    In aid of LC/MS and GC/MS technique, we will measure the metabolomics molecular profile in blood samples before and after treatment. The metabolomics measurement will help to detect the profile of all kinds of bile acid species, lipids species and amino acid species. The composition change of all these biological molecular induced by the treatment is our major interest rather than single molecular quantification

    Measured: 13 weeks

  11. Blood Incretin

    In aid of multiple ELISA based on xMAP Luminex technology, we will measure gut hormones, including Glp-1, GIP and PYY in ng/ml.

    Measured: 13 weeks

  12. Inflammation markers (hs-CRP, TNF-alfa, IL-6, and IL-8 etc. in ng/ml)

    Measured: 13 weeks

Timeline

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

  1. First posted10 Aug 2016 (estimated)
  2. Study start18 Aug 2016
  3. Primary completionDec 2017
  4. Study completionMay 2019 (estimated)

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02861261
Sponsor's protocol ID
CCEMD-20160301
Status last verified
Feb 2019
First submitted
1 Aug 2016
Last updated
12 Feb 2019
Results posted
No

Publications

  • Zhang Y, Gu Y, Ren H, Wang S, Zhong H, Zhao X, Ma J, Gu X, Xue Y, Huang S, Yang J, Chen L, Chen G, Qu S, Liang J, Qin L, Huang Q, Peng Y, Li Q, Wang X, Kong P, Hou G, Gao M, Shi Z, Li X, Qiu Y, Zou Y, Yang H, Wang J, Xu G, Lai S, Li J, Ning G, Wang W. Gut microbiome-related effects of berberine and probiotics on type 2 diabetes (the PREMOTE study). Nat Commun. 2020 Oct 6;11(1):5015. doi: 10.1038/s41467-020-18414-8.

    PubMed 33024120

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

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

Who may be eligible to take part?

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: status not confirmed, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

HbA1c (time frame: 13 weeks). 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 NCT02861261, which also lists 1 linked publication.

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 12 Feb 2019.

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