TCM and Nutrition for Diabetes Care Cohort

Study Overview
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Brief Summary
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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
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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.

Official Title
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Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort

Conditions
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Diabetes

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva microbiota | Saliva microbiota will be analyzed by metagenome sequencing | Baseline | 
| Saliva microbiota | Saliva microbiota will be analyzed by metagenome sequencing | The first week | 
| Saliva microbiota | Saliva microbiota will be analyzed by metagenome sequencing | The first month | 
| Saliva microbiota | Saliva microbiota will be analyzed by metagenome sequencing | The second month | 
| Saliva microbiota | Saliva microbiota will be analyzed by metagenome sequencing | The third month | 
| Fecal metabolomics | Targeted or untargeted fecal metabolomics are performed | Baseline | 
| Fecal metabolomics | Targeted or untargeted fecal metabolomics are performed | The first week | 
| Fecal metabolomics | Targeted or untargeted fecal metabolomics are performed | The first month | 
| Fecal metabolomics | Targeted or untargeted fecal metabolomics are performed | The second month | 
| Fecal metabolomics | Targeted or untargeted fecal metabolomics are performed | The third month | 
| Serum metabolomics | Targeted or untargeted serum metabolomics are performed | Baseline | 
| Serum metabolomics | Targeted or untargeted serum metabolomics are performed | The first week | 
| Serum metabolomics | Targeted or untargeted serum metabolomics are performed | The first month | 
| Serum metabolomics | Targeted or untargeted serum metabolomics are performed | The second month | 
| Serum metabolomics | Targeted or untargeted serum metabolomics are performed | The third month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, Nutrition, Gut microbiome, Metabolomics, Traditional Chinese medicine