Diabetes MellitusEarly Phase 1NCT05947370
Berberine on the Secretion of Incretin
A Early Phase 1 study testing Berberine Chloride in people with Diabetes Mellitus, run by Beijing Tongren Hospital at 2 sites in China.
Trial summary
Berberine (BBR) is the main active ingredient of the ancient Chinese herb medicine Coptis. The hypoglycemic effect of BBR has been demonstrated in numerous studies. Although BBR is safe and effective in the treatment of diabetes, its exact hypoglycemic mechanism is still unclear. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesChina
- Study dates
- 12 Oct 2022to 20 Apr 2023
- 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
- Voluntary participation in the trial and signed informed consent form.
- Healthy male subjects aged 18-45 years (including 18 and 45 years).
- No history of current or former diseases such as heart, liver, kidney, gastrointestinal tract, nervous system, respiratory system, mental disorders and metabolic abnormalities that the investigator considers meaningful; no physical examination, electrocardiogram, and laboratory examination results abnormality or abnormality has no clinical significance (subject to the judgment of the physician).
- Body mass index of 18.0-25.0 kg/cm2 (including 18.0 and 25.0 kg/cm2) and no centripetal obesity (waist-to-hip ratio less than 0.9).
- No family history of diabetes mellitus and obesity.
- Normal glucose tolerance (fasting blood glucose <6.1 mmol/L and 2h blood glucose <7.8mmol/L after oral administration of 75g glucose) and normal insulin secretion function (as judged by the investigator through the results of insulin release experiment).
- Able to communicate well with the investigator and complete the study in accordance with the study regulations.
Who cannot join
- Infection with hepatitis (A, B, or C), HIV and syphilis.
- Those with clear allergy to berberine hydrochloride or its preparation components; those with drug (including salicylic acid) allergy, history of allergic diseases or allergic constitution.
- Patients with hemolytic anemia and glucose-6-phosphate dehydrogenase deficiency.
- Those who have used any prescription medication, herbal medicine within 4 weeks prior to dosing and/or taken over-the-counter medication (except for subjects with occasional or restricted use of paracetamol), supplements (except for routine vitamin supplementation) within 2 weeks prior to dosing.
- Cumulative amount of blood loss (eg. blood donation) over 400mL within 3 months prior to baseline visit and during the study.
- Heavy smokers (25 or more cigarettes per day) and heavy drinkers (14 units of alcohol per week, 1 unit = 285ml of beer, or 25ml of spirits, or 100ml of wine).
Show all 9Show fewer
- Those with a history of substance abuse or positive urine test for prohibited drugs.
- Those who participated in any clinical trial within 1 month prior to the trial, or those who plan to participate in other clinical trials during or within 1 month after the end of the trial.
- Other circumstances that the investigator considers unsuitable for participation in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, 100730
Hao Wang
Beijing
About this study
Official title: The Effect of Berberine on the Secretion of Incretin in Normal Man
Berberine (BBR) is the main active ingredient of the ancient Chinese herb medicine Coptis. The hypoglycemic effect of BBR has been demonstrated in numerous studies. Although BBR is safe and effective in the treatment of diabetes, its exact hypoglycemic mechanism is still unclear. Jin-Kui Yang found that BBR can promote GLP-1 secretion from intestinal L cells in mice in vitro and in vivo, thereby achieving the effect of lowering blood glucose, but it is still unknown whether BBR can promote incretin secretion in humans. In this study, investigators plan to examine the effect of BBR on secretion of incretin in human.
- Conditions
- Diabetes Mellitus
- Being tested
- Berberine Chloride, Placebo
- 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 Chloride | Experimental | This study employed a randomized, double-blind, placebo-controlled, two-period crossover design: subjects were randomized into two groups of equal size. The random allocation was conducted by asking volunteers to select the randomized number generated by computer. Each number represented placebo or BBR, and each group has the same number of numbers. The dosing sequence in the first group was oral BBR in the first cycle and oral placebo in the second cycle. The second group was administered placebo in the first cycle and BBR in the second cycle. Take the second dose 14 days after the first dose. After the last dose, continue to observe for 14 days to watch for side effects. On each experimental day, after an overnight fast, the subjects received a single oral dose of 1 g of BBR or a corresponding dose of the placebo. Receives: Drug: Berberine Chloride; Drug: Placebo |
| Placebo control | Placebo comparator | This study employed a randomized, double-blind, placebo-controlled, two-period crossover design: subjects were randomized into two groups of equal size. The random allocation was conducted by asking volunteers to select the randomized number generated by computer. Each number represented placebo or BBR, and each group has the same number of numbers. The dosing sequence in the first group was oral BBR in the first cycle and oral placebo in the second cycle. The second group was administered placebo in the first cycle and BBR in the second cycle. Take the second dose 14 days after the first dose. After the last dose, continue to observe for 14 days to watch for side effects. On each experimental day, after an overnight fast, the subjects received a single oral dose of 1 g of BBR or a corresponding dose of the placebo. 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 GLP-1 levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean serum GLP-1 in the two groups during glucose tolerance test.
Measured: 4 hours
Differences of serum GIP levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean serum GIP levels in the two groups during glucose tolerance test.
Measured: 4 hours
Differences of blood glucose levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean blood glucose levels in the two groups during glucose tolerance test.
Measured: 4 hours
Secondary outcomes (6)
Differences of serum insulin levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean insulin levels in the two groups during glucose tolerance test.
Measured: The time frame is the same as Primary Outcome Measure 1
Differences of serum C-peptide levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean serum C-peptide levels in the two groups during glucose tolerance test.
Measured: 4 hours
Differences of serum potassium levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean serum potassium levels in the two groups during glucose tolerance test.
Measured: 4 hours
Differences of serum sodium levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean serum sodium levels in the two groups during glucose tolerance test.
Measured: 4 hours
Differences of serum chloride levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean serum chloride levels in the two groups during glucose tolerance test.
Measured: 4 hours
Differences of serum calcium levels between BBR and placebo treatment groups during the glucose tolerance test.
To compare the mean serum calcium levels in the two groups during glucose tolerance test.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start12 Oct 2022
- Primary completion6 Apr 2023
- Study completion20 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Kui Yang, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947370
- Sponsor's protocol ID
- BBR incretin
- Status last verified
- Jul 2023
- First submitted
- 4 Jun 2023
- Last updated
- 17 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lan J, Zhao Y, Dong F, Yan Z, Zheng W, Fan J, Sun G. Meta-analysis of the effect and safety of berberine in the treatment of type 2 diabetes mellitus, hyperlipemia and hypertension. J Ethnopharmacol. 2015 Feb 23;161:69-81. doi: 10.1016/j.jep.2014.09.049. Epub 2014 Dec 10.
PubMed 25498346Luthra A, Misra A. The marketing of unproven drugs for diabetes and dyslipidaemia in India. Lancet Diabetes Endocrinol. 2015 Oct;3(10):758-60. doi: 10.1016/S2213-8587(15)00328-9. No abstract available.
PubMed 26386988
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Berberine on the Secretion of Incretin in Normal Man
- ClinicalTrials.gov ID
- NCT05947370
- Acronym / sponsor ID
- BBR incretin
- Conditions
- Diabetes Mellitus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 6 Apr 2023 (actual)
- Study completion
- 20 Apr 2023 (actual)
- First posted
- 17 Jul 2023 (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 the main active ingredient of the ancient Chinese herb medicine Coptis. The hypoglycemic effect of BBR has been demonstrated in numerous studies. Although BBR is safe and effective in the treatment of diabetes, its exact hypoglycemic mechanism is still unclear. Jin-Kui Yang found that BBR can promote GLP-1 secretion from intestinal L cells in mice in vitro and in vivo, thereby achieving the effect of lowering blood glucose, but it is still unknown whether BBR can promote incretin secretion in humans. In this study, investigators plan to examine the effect of BBR on secretion of incretin in human.
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 Chloride | Experimental | Drug: Berberine Chloride, Drug: PlaceboThis study employed a randomized, double-blind, placebo-controlled, two-period crossover design: subjects were randomized into two groups of equal size. The random allocation was conducted by asking volunteers to select the randomized number generated by computer. Each number represented placebo or BBR, and each group has the same number of numbers. The dosing sequence in the first group was oral BBR in the first cycle and oral placebo in the second cycle. The second group was administered placebo in the first cycle and BBR in the second cycle. Take the second dose 14 days after the first dose. After the last dose, continue to observe for 14 days to watch for side effects. On each experimental day, after an overnight fast, the subjects received a single oral dose of 1 g of BBR or a corresponding dose of the placebo. |
| Placebo control | Placebo comparator | Drug: Berberine Chloride, Drug: PlaceboThis study employed a randomized, double-blind, placebo-controlled, two-period crossover design: subjects were randomized into two groups of equal size. The random allocation was conducted by asking volunteers to select the randomized number generated by computer. Each number represented placebo or BBR, and each group has the same number of numbers. The dosing sequence in the first group was oral BBR in the first cycle and oral placebo in the second cycle. The second group was administered placebo in the first cycle and BBR in the second cycle. Take the second dose 14 days after the first dose. After the last dose, continue to observe for 14 days to watch for side effects. On each experimental day, after an overnight fast, the subjects received a single oral dose of 1 g of BBR or a corresponding dose of the placebo. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Voluntary participation in the trial and signed informed consent form.
- Healthy male subjects aged 18-45 years (including 18 and 45 years).
- No history of current or former diseases such as heart, liver, kidney, gastrointestinal tract, nervous system, respiratory system, mental disorders and metabolic abnormalities that the investigator considers meaningful; no physical examination, electrocardiogram, and laboratory examination results abnormality or abnormality has no clinical significance (subject to the judgment of the physician).
- Body mass index of 18.0-25.0 kg/cm2 (including 18.0 and 25.0 kg/cm2) and no centripetal obesity (waist-to-hip ratio less than 0.9).
- No family history of diabetes mellitus and obesity.
Key exclusion criteria (9 listed)
- Infection with hepatitis (A, B, or C), HIV and syphilis.
- Those with clear allergy to berberine hydrochloride or its preparation components; those with drug (including salicylic acid) allergy, history of allergic diseases or allergic constitution.
- Patients with hemolytic anemia and glucose-6-phosphate dehydrogenase deficiency.
- Those who have used any prescription medication, herbal medicine within 4 weeks prior to dosing and/or taken over-the-counter medication (except for subjects with occasional or restricted use of paracetamol), supplements (except for routine vitamin supplementation) within 2 weeks prior to dosing.
- Cumulative amount of blood loss (eg. blood donation) over 400mL within 3 months prior to baseline visit and during the study.
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 Chloride, Placebo control |
| PlaceboPlacebo control | Drug | Berberine Chloride, Placebo control |
Primary outcome
Differences of serum GLP-1 levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
To compare the mean serum GLP-1 in the two groups during glucose tolerance test.
Differences of serum GIP levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
To compare the mean serum GIP levels in the two groups during glucose tolerance test.
Differences of blood glucose levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
To compare the mean blood glucose levels in the two groups during glucose tolerance test.
6 secondary outcomes
Differences of serum insulin levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: The time frame is the same as Primary Outcome Measure 1
Differences of serum C-peptide levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
Differences of serum potassium levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
Differences of serum sodium levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
Differences of serum chloride levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
Differences of serum calcium levels between BBR and placebo treatment groups during the glucose tolerance test.
Time frame: 4 hours
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 17 Jul 2023.
- Background: PubMed 25498346Lan J, Zhao Y, Dong F, Yan Z, Zheng W, Fan J, Sun G. Meta-analysis of the effect and safety of berberine in the treatment of type 2 diabetes mellitus, hyperlipemia and hypertension. J Ethnopharmacol. 2015 Feb 23;161:69-81. doi: 10.1016/j.jep.2014.09.049. Epub 2014 Dec 10.
- Background: PubMed 26386988Luthra A, Misra A. The marketing of unproven drugs for diabetes and dyslipidaemia in India. Lancet Diabetes Endocrinol. 2015 Oct;3(10):758-60. doi: 10.1016/S2213-8587(15)00328-9. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
2 sites 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 Beijing Tongren Hospital at 2 sites 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 9 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 17 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 2 sites 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 GLP-1 levels between BBR and placebo treatment groups during the glucose tolerance test. (time frame: 4 hours). The study lists 3 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 NCT05947370, 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 17 Jul 2023.