Type 1 DiabetesSBTT1DNCT07787754
The Effect of Sea Buckthorn Extract in Patients With Type 1 Diabetes
A study testing Sea buckthorn in people with Type 1 Diabetes, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing β-cells by autoreactive T cells. Sea buckthorn (SBT), a traditional Chinese medicine homologous to food, confers beneficial effects on the autoimmune system. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Sea buckthorn
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with Type 1 Diabetes Mellitus (T1DM) by an endocrinologist at a qualified medical institution.
- Aged between 18 and 75 years (inclusive).
- Maintained a stable anti-diabetic medication regimen for at least 3 months prior to enrollment and is expected to remain stable throughout the study duration.
- Glycated Hemoglobin A1c (HbA1c) ≤ 8%.
Who cannot join
- Patients with other types of diabetes (including Type 2 Diabetes, monogenic diabetes, diseases of the exocrine pancreas, and drug- or chemical-induced diabetes).
- History of acute metabolic events, specifically Diabetic Ketoacidosis (DKA) or Hyperosmolar Hyperglycemic State (HHS), within the past 6 months.
- Current use of medications that may affect immune function, including immunomodulatory or immunosuppressive treatment, steroids, or antibiotics in the previous 3 months.
- Pregnant or lactating women.
- Patients with abnormal renal function or abnormal liver function.
- Patients with malignant diseases.
- Patients with acute or chronic infection.
- Patients with a history of psychiatric or neurological disorders.
Trial locations and contacts
1 site in 1 country.
China1 site
The first affiliated hospital of guangzhou medical University
Guangzhou, Guangdong, 510120
About this study
Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing β-cells by autoreactive T cells. Sea buckthorn (SBT), a traditional Chinese medicine homologous to food, confers beneficial effects on the autoimmune system. Whether SBT regulates the glucose metabolism and immune microenvironment in T1D remains unknown. This study aims to investigate the impact of SBT on glycemic control and T-cell balance in patients with T1D. Patients with T1D consumed 10g of SBT extracts daily for 12 weeks. Clinical and experimental data were analyzed at the baseline and after 12 weeks of SBT treatment. Healthy controls were enrolled with no treatment. Side adverse effects will be recorded in this study.
- Conditions
- Type 1 Diabetes
- Being tested
- Sea buckthorn
- Keywords
- Sea buckthorn extract, type 1 diabetes, T cell, islet β-cell, glucose metabolism
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sea buckthornDietary supplement
Sea buckthorn extract One of the differences between these two studies and ours is that the SBT used in our study is extracted by supercritical extraction technology without additional components.
| Study group | Role | What they receive |
|---|---|---|
| Healthy control | No intervention | The healthy controls received no interventions. |
| Type 1 diabetes | Experimental | Patients received oral administration of 10g of SBT extracts daily, dissolved in 100 ml water at 40℃, taken before breakfast for 12 weeks, while continuing their current antihyperglycemic medication. Receives: Dietary Supplement: Sea buckthorn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose control
To investigate the effect of SBT on glucose metabolism in patients, fasting glucose level in mmol/L were measured after patients with T1D were administered a daily oral dose of 10g of SBT for 12 weeks.
Measured: From enrollment to the end of treatment at 12 weeks.
Secondary outcomes (1)
T-cell population
Fresh whole blood specimens were collected from patients with T1DM. T cell populations were analyzed on the flow cytometry.
Measured: From enrollment to the end of treatment at 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Jan 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoyan Chen, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Xiaoyan Chen, Doctor, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07787754
- Sponsor's protocol ID
- No. 1872022
- Other IDs
- DKME202214
- Acronym
- SBTT1D
- Status last verified
- Aug 2026
- First submitted
- 23 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sea Buckthorn Extract in Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07787754
- Acronym / sponsor ID
- SBTT1D / No. 1872022
- Conditions
- Type 1 Diabetes
- Keywords
- Sea buckthorn extract, type 1 diabetes, T cell, islet β-cell, glucose metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Aug 2026 (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.
Type 1 diabetes (T1D) is an autoimmune disease characterized by the destruction of insulin-producing β-cells by autoreactive T cells. Sea buckthorn (SBT), a traditional Chinese medicine homologous to food, confers beneficial effects on the autoimmune system. Whether SBT regulates the glucose metabolism and immune microenvironment in T1D remains unknown. This study aims to investigate the impact of SBT on glycemic control and T-cell balance in patients with T1D. Patients with T1D consumed 10g of SBT extracts daily for 12 weeks. Clinical and experimental data were analyzed at the baseline and after 12 weeks of SBT treatment. Healthy controls were enrolled with no treatment. Side adverse effects will be recorded in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy control | No intervention | –The healthy controls received no interventions. |
| Type 1 diabetes | Experimental | Dietary Supplement: Sea buckthornPatients received oral administration of 10g of SBT extracts daily, dissolved in 100 ml water at 40℃, taken before breakfast for 12 weeks, while continuing their current antihyperglycemic medication. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients diagnosed with Type 1 Diabetes Mellitus (T1DM) by an endocrinologist at a qualified medical institution.
- Aged between 18 and 75 years (inclusive).
- Maintained a stable anti-diabetic medication regimen for at least 3 months prior to enrollment and is expected to remain stable throughout the study duration.
- Glycated Hemoglobin A1c (HbA1c) ≤ 8%.
Key exclusion criteria (8 listed)
- Patients with other types of diabetes (including Type 2 Diabetes, monogenic diabetes, diseases of the exocrine pancreas, and drug- or chemical-induced diabetes).
- History of acute metabolic events, specifically Diabetic Ketoacidosis (DKA) or Hyperosmolar Hyperglycemic State (HHS), within the past 6 months.
- Current use of medications that may affect immune function, including immunomodulatory or immunosuppressive treatment, steroids, or antibiotics in the previous 3 months.
- Pregnant or lactating women.
- Patients with abnormal renal function or abnormal liver function.
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 |
|---|---|---|
| Sea buckthornSea buckthorn extract One of the differences between these two studies and ours is that the SBT used in our study is extracted by supercritical extraction technology without additional components. | Dietary supplement | Type 1 diabetes |
Primary outcome
Glucose control
Time frame: From enrollment to the end of treatment at 12 weeks.
To investigate the effect of SBT on glucose metabolism in patients, fasting glucose level in mmol/L were measured after patients with T1D were administered a daily oral dose of 10g of SBT for 12 weeks.
1 secondary outcome
T-cell population
Time frame: From enrollment to the end of treatment at 12 weeks.
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 26 Aug 2026.
- 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.
Xiaoyan Chen, Doctor principal investigator
The First Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sea buckthorn in people with Type 1 Diabetes, run by The First Affiliated Hospital of Guangzhou Medical University 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 4 inclusion and 8 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 26 Aug 2026. 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. 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?
Glucose control (time frame: From enrollment to the end of treatment at 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.