Westlake Diabetes Cohort

Sponsor

Westlake University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05312450

Collaborator

Zhejiang Provincial Tongde Hospital (Other)

2,000

Enrollment

Location

43.7

Anticipated Duration (Months)

45.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes

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

Study Type:

Observational

Anticipated Enrollment :

2000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Diabetes Cohort From A Clinic for Patients With Integrated Traditional Chinese Medicine and Nutrition Treatments

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 30, 2025

Outcome Measures

Primary Outcome Measures

gut microbiome [Baseline]
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome [The first week]
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome [The first month]
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome [The second month]
Fecal microbiome will be analyzed by metagenome sequencing
gut microbiome [The third month]
Fecal microbiome will be analyzed by metagenome sequencing
The change of postprandial blood glucose [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 Outcome Measures

Saliva microbiota [Baseline]
Saliva microbiota will be analyzed by metagenome sequencing
Saliva microbiota [The first week]
Saliva microbiota will be analyzed by metagenome sequencing
Saliva microbiota [The first month]
Saliva microbiota will be analyzed by metagenome sequencing
Saliva microbiota [The second month]
Saliva microbiota will be analyzed by metagenome sequencing
Saliva microbiota [The third month]
Saliva microbiota will be analyzed by metagenome sequencing
Fecal metabolomics [Baseline]
Targeted or untargeted fecal metabolomics are performed
Fecal metabolomics [The first week]
Targeted or untargeted fecal metabolomics are performed
Fecal metabolomics [The first month]
Targeted or untargeted fecal metabolomics are performed
Fecal metabolomics [The second month]
Targeted or untargeted fecal metabolomics are performed
Fecal metabolomics [The third month]
Targeted or untargeted fecal metabolomics are performed
Serum metabolomics [Baseline]
Targeted or untargeted serum metabolomics are performed
Serum metabolomics [The first week]
Targeted or untargeted serum metabolomics are performed
Serum metabolomics [The first month]
Targeted or untargeted serum metabolomics are performed
Serum metabolomics [The second month]
Targeted or untargeted serum metabolomics are performed
Serum metabolomics [The third month]
Targeted or untargeted serum metabolomics are performed

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.