TCM and Nutrition for Diabetes Care Cohort (TCM-Nut-DC)

Integrated Traditional Chinese Medicine and Nutrition Treatments for Diabetes Care Cohort

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.

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310024
      • Recruiting
      • Westlake University
      • Contact: Ju-Sheng Zheng, PhD; Phone Number: 86-0571-86915303; Email: zhengjusheng@westlake.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Westlake University
• Collaborators: Zhejiang Provincial Tongde Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: December 2, 2021
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Estimated): November 17, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Diabetes; Metabolomics; Nutrition; Traditional Chinese medicine; Gut microbiome
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 20211117ZJS001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No