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.

Completed

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

Official record

Search all trials

Trial summary

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

Other trials in China

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 groups in NCT05947370
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.

12 Oct 202220 Apr 2023

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)

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 25498346
Luthra 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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)

All Diabetes Mellitus trials

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.

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.