Diabetes MellitusEarly Phase 1BBR HCNCT03972215
Berberine Hyperglycemic Clamp
A Early Phase 1 study testing Berberine Chloride in people with Diabetes Mellitus, run by Jin-Kui Yang at 1 site in China.
Trial summary
Berberine (BBR) is a traditional Chinese medicine used to treat diabetes mellitus for thousands of years in China. The glucose-lowering effect of BBR has been confirmed in numerous studies. Nevertheless, the detailed mechanisms of action through which BBR exerts its effects are not yet fully elucidated. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Berberine Chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2019to 17 Feb 2020
- Phase
- Early Phase 1
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult healthy male, aged ≥18 and ≤45 years old.
- Subject/ legal representative is able to understand and sign informed consent form.
- Body mass index (BMI) 18-25 kg/m2.
- Normal oral glucose tolerance test prior to study.
- No family history of diabetes mellitus.
- No medication treatment within 4 weeks prior to baseline visit and during the study.
- Willing and able to comply with all study-related procedures, including not incorporating significant changes in diet.
Who cannot join
- Infection with hepatitis (A, B, or C), HIV and syphilis.
- History of allergic reaction to berberine or any component in the formulation of the study drugs.
- Cumulative amount of blood loss (eg. blood donation) over 400mL within 3 months prior to baseline visit and during the study.
- Alcohol drinking within 2 weeks prior to baseline visit and during the study.
- Use of illegal drugs or positive in urine drugs screen.
- Smoke during the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
About this study
Official title: Effect of Berberine on Insulin Release at a High Blood Glucose Level in Normal Man
Berberine (BBR) is a traditional Chinese medicine used to treat diabetes mellitus for thousands of years in China. The glucose-lowering effect of BBR has been confirmed in numerous studies. Nevertheless, the detailed mechanisms of action through which BBR exerts its effects are not yet fully elucidated. In previous data, Jin-Kui Yang found that BBR could promote insulin secretion in mice and isolated islets. In this current study, investigators plan to examine the insulinotropic effect of BBR in human through hyperglycemic clamp method.
- Conditions
- Diabetes Mellitus
- Being tested
- Berberine Chloride, Placebo
- Keywords
- Hyperglycemic Clamp
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berberine ChlorideDrug
Traditional Chinese Medicine
PlaceboDrug
Placebo Control
| Study group | Role | What they receive |
|---|---|---|
| Berberine treatment | Experimental | Not described Receives: Drug: Berberine Chloride; Drug: Placebo |
| Placebo control | Placebo comparator | Not described Receives: Drug: Berberine Chloride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
To compare the mean serum insulin levels in the two groups during hyperglycemic clamp study.
Measured: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
To compare the mean serum C-peptide levels in the two groups during hyperglycemic clamp study.
Measured: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Secondary outcomes (2)
Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
To compare the mean glucose infusion rates in the two groups during hyperglycemic clamp study.
Measured: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Differences of blood glucose levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
To compare the mean blood glucose levels in the two groups during hyperglycemic clamp study.
Measured: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start1 Oct 2019
- Primary completion20 Jan 2020
- Study completion17 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jin-Kui Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin-Kui Yang, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03972215
- Sponsor's protocol ID
- BBR CLAMP
- Acronym
- BBR HC
- Status last verified
- Jul 2023
- First submitted
- 29 May 2019
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao MM, Lu J, Li S, Wang H, Cao X, Li Q, Shi TT, Matsunaga K, Chen C, Huang H, Izumi T, Yang JK. Berberine is an insulin secretagogue targeting the KCNH6 potassium channel. Nat Commun. 2021 Sep 23;12(1):5616. doi: 10.1038/s41467-021-25952-2.
PubMed 34556670
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Berberine on Insulin Release at a High Blood Glucose Level in Normal Man
- ClinicalTrials.gov ID
- NCT03972215
- Acronym / sponsor ID
- BBR HC / BBR CLAMP
- Conditions
- Diabetes Mellitus
- Keywords
- Hyperglycemic Clamp
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Jin-Kui YangUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 20 Jan 2020 (actual)
- Study completion
- 17 Feb 2020 (actual)
- First posted
- 3 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Berberine (BBR) is a traditional Chinese medicine used to treat diabetes mellitus for thousands of years in China. The glucose-lowering effect of BBR has been confirmed in numerous studies. Nevertheless, the detailed mechanisms of action through which BBR exerts its effects are not yet fully elucidated. In previous data, Jin-Kui Yang found that BBR could promote insulin secretion in mice and isolated islets. In this current study, investigators plan to examine the insulinotropic effect of BBR in human through hyperglycemic clamp method.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine treatment | Experimental | Drug: Berberine Chloride, Drug: Placebo |
| Placebo control | Placebo comparator | Drug: Berberine Chloride, Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult healthy male, aged ≥18 and ≤45 years old.
- Subject/ legal representative is able to understand and sign informed consent form.
- Body mass index (BMI) 18-25 kg/m2.
- Normal oral glucose tolerance test prior to study.
- No family history of diabetes mellitus.
Key exclusion criteria (6 listed)
- Infection with hepatitis (A, B, or C), HIV and syphilis.
- History of allergic reaction to berberine or any component in the formulation of the study drugs.
- Cumulative amount of blood loss (eg. blood donation) over 400mL within 3 months prior to baseline visit and during the study.
- Alcohol drinking within 2 weeks prior to baseline visit and during the study.
- Use of illegal drugs or positive in urine drugs screen.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Berberine ChlorideTraditional Chinese Medicine | Drug | Berberine treatment, Placebo control |
| PlaceboPlacebo Control | Drug | Berberine treatment, Placebo control |
Primary outcome
Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
Time frame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
To compare the mean serum insulin levels in the two groups during hyperglycemic clamp study.
Differences of serum C-peptide levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
Time frame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
To compare the mean serum C-peptide levels in the two groups during hyperglycemic clamp study.
2 secondary outcomes
Differences of glucose infusion rates between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
Time frame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Differences of blood glucose levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study.
Time frame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Derived from this study: PubMed 34556670Zhao MM, Lu J, Li S, Wang H, Cao X, Li Q, Shi TT, Matsunaga K, Chen C, Huang H, Izumi T, Yang JK. Berberine is an insulin secretagogue targeting the KCNH6 potassium channel. Nat Commun. 2021 Sep 23;12(1):5616. doi: 10.1038/s41467-021-25952-2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Berberine Chloride in people with Diabetes Mellitus, run by Jin-Kui Yang 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?
The sponsor lists 7 inclusion and 6 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 10 Jul 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Differences of serum insulin levels between BBR and placebo treatment groups during the 2-hour hyperglycemic clamp study. (time frame: Single dosage for one experiment and crossover repeat once after 2 weeks washout period). The study lists 2 primary outcomes in all. 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 NCT03972215, 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 10 Jul 2023.