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Completed

NCT Number: NCT05312450

TCM and Nutrition 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Westlake University

Hangzhou, Zhejiang, 310024, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Major special diseases, such as mental system diseases or other cognitive impairment, cancer and other malignant wasting diseases.

Treatment and study plan

Primary outcomes

  1. gut microbiome

    Time frame: Baseline

    Fecal microbiome will be analyzed by metagenome sequencing

  2. gut microbiome

    Time frame: The first week

    Fecal microbiome will be analyzed by metagenome sequencing

  3. gut microbiome

    Time frame: The first month

    Fecal microbiome will be analyzed by metagenome sequencing

  4. gut microbiome

    Time frame: The second month

    Fecal microbiome will be analyzed by metagenome sequencing

  5. gut microbiome

    Time frame: The third month

    Fecal microbiome will be analyzed by metagenome sequencing

  6. 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

Secondary outcomes

  1. Fecal metabolomics

    Time frame: Baseline

    Targeted or untargeted fecal metabolomics are performed

  2. Fecal metabolomics

    Time frame: The first week

    Targeted or untargeted fecal metabolomics are performed

  3. Fecal metabolomics

    Time frame: The first month

    Targeted or untargeted fecal metabolomics are performed

  4. Fecal metabolomics

    Time frame: The second month

    Targeted or untargeted fecal metabolomics are performed

  5. Fecal metabolomics

    Time frame: The third month

    Targeted or untargeted fecal metabolomics are performed

  6. Serum metabolomics

    Time frame: Baseline

    Targeted or untargeted serum metabolomics are performed

  7. Serum metabolomics

    Time frame: The first week

    Targeted or untargeted serum metabolomics are performed

  8. Serum metabolomics

    Time frame: The first month

    Targeted or untargeted serum metabolomics are performed

  9. Serum metabolomics

    Time frame: The second month

    Targeted or untargeted serum metabolomics are performed

  10. Serum metabolomics

    Time frame: The third month

    Targeted or untargeted serum metabolomics are performed

Sponsors and collaborators

Lead sponsor

Westlake University

Other

Collaborators

  • Zhejiang Provincial Tongde Hospital

Registry information

Official study title

Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort

Acronym: TCM-Nut-DC

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2022
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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