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Technical research on Clinical Observation of Multi-dimensional state Characterization and Construction of intelligent early warning Model in Prediabetic population with liver Depression and Qi Stagnation type

Research on Key Technologies of Multi-dimensional State Characterization intelligent early warning model Construction and Acupuncture Intervention Strategy for Prediabetic Population with Liver Depression and Qi Stagnation Type

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2025002362
Enrollment
Unknown
Registered
2025-12-01
Start date
2024-08-02
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pre-diabetes

Interventions

Patients with type 2 diabetes:No intervention measures pure observation
People with prediabetes:No intervention measures pure observation
Healthy volunteer:No intervention measures pure observation

Sponsors

Affiliated Hospital of Changchun University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

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

MeasureTime frame
Fasting blood glucose;2h-Fasting blood glucose;Glycosylated hemoglobin;

Secondary

MeasureTime 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

Public ContactHongfeng Wang / Yangyang Liu

Changchun University of Chinese Medicine / Affiliated Hospital of Changchun University of Chinese Medicine

ccwhf@126.com13943193886 13578879523

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026