Clinical trial NCT05312450: TCM and Nutrition for Diabetes Care Cohort
Official title: Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: Diabetes
Nutrition
Gut microbiome
Metabolomics
Traditional Chinese medicine
Lead sponsor: Westlake University
Sponsor class: OTHER
Collaborators: name: Zhejiang Provincial Tongde Hospital
First posted: 2022-04-05
Enrollment: 515
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: gut microbiome
timeFrame: Baseline
measure: gut microbiome
timeFrame: The first week
measure: gut microbiome
timeFrame: The first month
measure: gut microbiome
timeFrame: The second month
measure: gut microbiome
timeFrame: The third month
measure: The change of postprandial blood glucose
timeFrame: Up to three months
Secondary outcomes:
measure: Fecal metabolomics
timeFrame: Baseline
measure: Fecal metabolomics
timeFrame: The first week
measure: Fecal metabolomics
timeFrame: The first month
measure: Fecal metabolomics
timeFrame: The second month
measure: Fecal metabolomics
timeFrame: The third month
measure: Serum metabolomics
timeFrame: Baseline
measure: Serum metabolomics
timeFrame: The first week
measure: Serum metabolomics
timeFrame: The first month
measure: Serum metabolomics
timeFrame: The second month
measure: Serum metabolomics
timeFrame: The third month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Westlake University
state: Zhejiang
Study officials:
References: