Westlake University
Hangzhou, Zhejiang, 310024, China
NCT Number: NCT05312450
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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Notify Me18 year and older
All sexes
Observational
Hangzhou, Zhejiang, 310024, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Fecal microbiome will be analyzed by metagenome sequencing
Time frame: The first week
Fecal microbiome will be analyzed by metagenome sequencing
Time frame: The first month
Fecal microbiome will be analyzed by metagenome sequencing
Time frame: The second month
Fecal microbiome will be analyzed by metagenome sequencing
Time frame: The third month
Fecal microbiome will be analyzed by metagenome sequencing
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
Time frame: Baseline
Targeted or untargeted fecal metabolomics are performed
Time frame: The first week
Targeted or untargeted fecal metabolomics are performed
Time frame: The first month
Targeted or untargeted fecal metabolomics are performed
Time frame: The second month
Targeted or untargeted fecal metabolomics are performed
Time frame: The third month
Targeted or untargeted fecal metabolomics are performed
Time frame: Baseline
Targeted or untargeted serum metabolomics are performed
Time frame: The first week
Targeted or untargeted serum metabolomics are performed
Time frame: The first month
Targeted or untargeted serum metabolomics are performed
Time frame: The second month
Targeted or untargeted serum metabolomics are performed
Time frame: The third month
Targeted or untargeted serum metabolomics are performed
Westlake University
Other
Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort
Acronym: TCM-Nut-DC
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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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