TCM and Nutrition for Diabetes Care Cohort

Last updated: November 14, 2023
Sponsor: Westlake University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetic Gastroparesis

Diabetic Vitreous Hemorrhage

Treatment

N/A

Clinical Study ID

NCT05312450
20211117ZJS001
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Comply with the diagnosis of diabetes in western medicine and the diagnostic criteriaof type 2 diabetes in the "Guiding Principles for Clinical Research of New ChineseMedicines"; volunteer to participate and sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Major special diseases, such as mental system diseases or other cognitive impairment,cancer and other malignant wasting diseases.

Study Design

Total Participants: 600
Study Start date:
March 10, 2022
Estimated Completion Date:
November 01, 2024

Study 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.

Connect with a study center

  • Westlake University

    Hangzhou, Zhejiang 310024
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.