DiabetesTCM-Nut-DCNCT05312450
TCM and Nutrition for Diabetes Care Cohort
An observational study of Diabetes, run by Westlake University at 1 site in China.
Trial summary
This is a prospective cohort study that takes place in a clinic of Hangzhou, China. The aim of this study is to explore the molecular mechanism of special Chinese medicine formula combined with personalized nutrition to assist the treatment of diabetes from the aspect of multi-omics view. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- How many people
- 515 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 1 Jun 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetes who are volunteer to participate and sign the informed consent form, and without special diseases, such as mental system diseases or other cognitive impairment, cancer and other malignant wasting diseases.
Who may be able to join
- Comply with the diagnosis of diabetes in western medicine and the diagnostic criteria of type 2 diabetes in the "Guiding Principles for Clinical Research of New Chinese Medicines"; volunteer to participate and sign the informed consent form.
Who cannot join
- Major special diseases, such as mental system diseases or other cognitive impairment, cancer and other malignant wasting diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort
This is a prospective cohort study that takes place in a clinic of Hangzhou, China. The aim of this study is to explore the molecular mechanism of special Chinese medicine formula combined with personalized nutrition to assist the treatment of diabetes from the aspect of multi-omics view. This study also aims to explore the relationship between gut microbiome and blood glucose in the process of personalized diet intervention.
Read the detailed description
Traditional Chinese medicine has a history of more than two thousand years in China for treating diabetes based on the theory of "medicine and food homology". Modern pharmacological research and clinical research have shown that proprietary Chinese medicines and Chinese herbal decoctions have the advantages of overall regulation and fewer side effects for the treatment of type 2 diabetes and its complications. Meanwhile, dietary intervention is essential for the treatment of diabetes. In a clinic of Hangzhou, China, Chinese medicine doctors use a special Chinese medicine formula combined with dietary intervention to treat diabetes, and achieve good therapeutic effects without obvious adverse effects. The diet treatment plan is based on the results of the patient's food tolerance test, and dietary recommendations are provided based on the food glycemic index. In the first week of the treatment, patients are limit carbohydrate intake. Patients are evaluated every one month, and are instructed to choose foods rich in fiber and low glycemic index to reduce blood sugar fluctuations. Every patient is followed by one nutritionist, who provides dietary instructions for the patient. Patients use fingertip blood glucose to detect postprandial blood glucose. One course of treatment is three months, all patients will be treated for one course in this study. During the treatment, the dosage of western medicine hypoglycemic drugs was adjusted according to the Chinese Diabetes Prevention and Control Guidelines. Both Chinese medicine prescriptions and nutrition prescriptions were followed for the treatment to work towards the direction of drug injections-only oral drugs-drug reduction-drug discontinuation-drug discontinuation and stability-cure. Baseline information of demography, lifestyle, diet, physical activity, comorbidity, medication history, and so on is collected when patients enter the clinic to receive treatments. Meanwhile, the saliva, stool, fasting blood, fasting urine samples are collected. During the treatment, the dietary information is collected through photos taken by patients themselves. The saliva, stool, fasting blood, fasting urine samples are also collected when the patients re-enter the clinic for reexamination at the first week, and every one month.
- Conditions
- Diabetes
- Keywords
- Diabetes, Nutrition, Gut microbiome, Metabolomics, Traditional Chinese medicine
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
Measured: Baseline
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
Measured: The first week
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
Measured: The first month
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
Measured: The second month
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
Measured: The third month
The change of postprandial blood glucose
Fingertip blood glucose was used to detect postprandial blood glucose. The change of postprandial blood glucose among the three months will be measured
Measured: Up to three months
Secondary outcomes (10)
Fecal metabolomics
Targeted or untargeted fecal metabolomics are performed
Measured: Baseline
Fecal metabolomics
Targeted or untargeted fecal metabolomics are performed
Measured: The first week
Fecal metabolomics
Targeted or untargeted fecal metabolomics are performed
Measured: The first month
Fecal metabolomics
Targeted or untargeted fecal metabolomics are performed
Measured: The second month
Fecal metabolomics
Targeted or untargeted fecal metabolomics are performed
Measured: The third month
Serum metabolomics
Targeted or untargeted serum metabolomics are performed
Measured: Baseline
Serum metabolomics
Targeted or untargeted serum metabolomics are performed
Measured: The first week
Serum metabolomics
Targeted or untargeted serum metabolomics are performed
Measured: The first month
Serum metabolomics
Targeted or untargeted serum metabolomics are performed
Measured: The second month
Serum metabolomics
Targeted or untargeted serum metabolomics are performed
Measured: The third month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start10 Mar 2022
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 515 participants (actual)
Sponsor and investigators
- Lead sponsor
- Westlake University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312450
- Sponsor's protocol ID
- 20211117ZJS001
- Acronym
- TCM-Nut-DC
- Status last verified
- May 2025
- First submitted
- 2 Dec 2021
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort
- ClinicalTrials.gov ID
- NCT05312450
- Acronym / sponsor ID
- TCM-Nut-DC / 20211117ZJS001
- Conditions
- Diabetes
- Keywords
- Diabetes, Nutrition, Gut microbiome, Metabolomics, Traditional Chinese medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 515 participants (actual)
- Lead sponsor
- Westlake UniversityUniversity, hospital or other
- Collaborators
- Zhejiang Provincial Tongde Hospital
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 5 Apr 2022 (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.
This is a prospective cohort study that takes place in a clinic of Hangzhou, China. The aim of this study is to explore the molecular mechanism of special Chinese medicine formula combined with personalized nutrition to assist the treatment of diabetes from the aspect of multi-omics view. This study also aims to explore the relationship between gut microbiome and blood glucose in the process of personalized diet intervention.
Detailed description
Traditional Chinese medicine has a history of more than two thousand years in China for treating diabetes based on the theory of "medicine and food homology". Modern pharmacological research and clinical research have shown that proprietary Chinese medicines and Chinese herbal decoctions have the advantages of overall regulation and fewer side effects for the treatment of type 2 diabetes and its complications. Meanwhile, dietary intervention is essential for the treatment of diabetes. In a clinic of Hangzhou, China, Chinese medicine doctors use a special Chinese medicine formula combined with dietary intervention to treat diabetes, and achieve good therapeutic effects without obvious adverse effects. The diet treatment plan is based on the results of the patient's food tolerance test, and dietary recommendations are provided based on the food glycemic index. In the first week of the treatment, patients are limit carbohydrate intake. Patients are evaluated every one month, and are instructed to choose foods rich in fiber and low glycemic index to reduce blood sugar fluctuations. Every patient is followed by one nutritionist, who provides dietary instructions for the patient. Patients use fingertip blood glucose to detect postprandial blood glucose. One course of treatment is three months, all patients will be treated for one course in this study. During the treatment, the dosage of western medicine hypoglycemic drugs was adjusted according to the Chinese Diabetes Prevention and Control Guidelines. Both Chinese medicine prescriptions and nutrition prescriptions were followed for the treatment to work towards the direction of drug injections-only oral drugs-drug reduction-drug discontinuation-drug discontinuation and stability-cure. Baseline information of demography, lifestyle, diet, physical activity, comorbidity, medication history, and so on is collected when patients enter the clinic to receive treatments. Meanwhile, the saliva, stool, fasting blood, fasting urine samples are collected. During the treatment, the dietary information is collected through photos taken by patients themselves. The saliva, stool, fasting blood, fasting urine samples are also collected when the patients re-enter the clinic for reexamination at the first week, and every one month.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetes who are volunteer to participate and sign the informed consent form, and without special diseases, such as mental system diseases or other cognitive impairment, cancer and other malignant wasting diseases.
Key inclusion criteria (1 listed)
- Comply with the diagnosis of diabetes in western medicine and the diagnostic criteria of type 2 diabetes in the "Guiding Principles for Clinical Research of New Chinese Medicines"; volunteer to participate and sign the informed consent form.
Key exclusion criteria (1 listed)
- Major special diseases, such as mental system diseases or other cognitive impairment, cancer and other malignant wasting diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
gut microbiome
Time frame: Baseline
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome
Time frame: The first week
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome
Time frame: The first month
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome
Time frame: The second month
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome
Time frame: The third month
Fecal microbiome will be analyzed by metagenome sequencing
The change of postprandial blood glucose
Time frame: Up to three months
Fingertip blood glucose was used to detect postprandial blood glucose. The change of postprandial blood glucose among the three months will be measured
10 secondary outcomes
Fecal metabolomics
Time frame: Baseline
Fecal metabolomics
Time frame: The first week
Fecal metabolomics
Time frame: The first month
Fecal metabolomics
Time frame: The second month
Fecal metabolomics
Time frame: The third month
Serum metabolomics
Time frame: Baseline
Serum metabolomics
Time frame: The first week
Serum metabolomics
Time frame: The first month
Serum metabolomics
Time frame: The second month
Serum metabolomics
Time frame: The third month
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 13 Jun 2025.
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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?
An observational study of Diabetes, run by Westlake 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 1 inclusion and 1 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 13 Jun 2025. 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?
gut microbiome (time frame: Baseline). The study lists 6 primary outcomes in all. 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 13 Jun 2025.