TCM and Nutrition for Diabetes Care Cohort
TCM-Nut-DC
Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort
1 other identifier
observational
515
1 country
1
Brief 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. This study also aims to explore the relationship between gut microbiome and blood glucose in the process of personalized diet intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2021
CompletedStudy Start
First participant enrolled
March 10, 2022
CompletedFirst Posted
Study publicly available on registry
April 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedJune 13, 2025
May 1, 2025
1.2 years
December 2, 2021
June 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
Baseline
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
The first week
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
The first month
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
The second month
gut microbiome
Fecal microbiome will be analyzed by metagenome sequencing
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
Up to three months
Secondary Outcomes (10)
Fecal metabolomics
Baseline
Fecal metabolomics
The first week
Fecal metabolomics
The first month
Fecal metabolomics
The second month
Fecal metabolomics
The third month
- +5 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Major special diseases, such as mental system diseases or other cognitive impairment, cancer and other malignant wasting diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Westlake Universitylead
- Zhejiang Provincial Tongde Hospitalcollaborator
Study Sites (1)
Westlake University
Hangzhou, Zhejiang, 310024, China
Biospecimen
Biospecimen including fecal, saliva, fasting boold, and fasting urine samples will be collected
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 2, 2021
First Posted
April 5, 2022
Study Start
March 10, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
June 13, 2025
Record last verified: 2025-05