Pre-diabetes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: I. Inclusion Criteria for Prediabetes: 1) Meets the diagnostic criteria for prediabetes as outlined in the 2023 Chinese Expert Consensus on Prediabetes Intervention in Adults; 2) Age: 18–70 years; 3) Not currently taking other hypoglycemic or lipid-lowering medications; 4) Willing to participate in the study, sign an informed consent form, and accept treatment and all required tests. II. Inclusion Criteria for Type 2 Diabetes: 1) Meets diagnostic criteria for type 2 diabetes as outlined in the Clinical Evidence-Based Practice Guidelines for Traditional Chinese Medicine in Diabetes (2016) and the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition); 2) Age: 18–70 years; 3) First-time diagnosis of type 2 diabetes with no prior treatment; 4) Willingness to participate in the study, sign an informed consent form, and undergo treatment and all required tests. III. Inclusion Criteria for Healthy Volunteers: 1) Normal blood glucose levels; 2) Age 18–70 years; 3) BMI 18.5–23.9; 4) No history of chronic diseases or medication use within the past two years.
Exclusion criteria
Exclusion criteria: 1) Patients diagnosed with type 1 diabetes, gestational diabetes, secondary diabetes, or other special types of diabetes; 2) Patients who have taken or are currently taking hypoglycemic agents or other prescription medications within the past 2 months; 3) Patients with severe cardiovascular or cerebrovascular diseases, other serious conditions, mental disorders, or behavioral inhibitions; 4) Patients who exhibit fear or aversion to acupuncture therapy and refuse to undergo acupuncture treatment; 5) Pregnant or lactating women, or those planning pregnancy in the near future; 6) Participants currently enrolled in or having participated in other clinical trials within the past 3 months; 7) Individuals who have used high-dose probiotics within the past 6 months or applied topical antibiotics or other agents affecting oral metabolite detection within the past 7 days; 8) Individuals unable to undergo MRI scanning for any reason; 9) Participants deemed unsuitable for study enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting blood glucose;2h-Fasting blood glucose;Glycosylated hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Triglycerides;Insulin Resistance Index;2h postprandial insulin;Body mass index;High-density lipoprotein cholesterol;Waist-hip ratio;Low density lipoprotein cholesterol;Evaluation table of Chinese medicine syndrome of prediabetes;Cholesterol;Fasting insulin;Islet beta cell function index;Glycated serum protein; | — |
Countries
China
Contacts
Changchun University of Chinese Medicine / Affiliated Hospital of Changchun University of Chinese Medicine