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A clinical cross-sectional study on the biological basis of type 2 diabetes patients with ''stagnant heat'' stage based on the ''State-Target Strategy''

A clinical cross-sectional study on the biological basis of type 2 diabetes patients with ''stagnant heat'' stage based on the ''State-Target Strategy''

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2022000087
Enrollment
Unknown
Registered
2022-08-22
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

diabetes

Interventions

healthy people:Nothing
Pre-diabetic (depressive stage) population:Nothing
Early-stage diabetes (hot stage) population:Nothing

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria - Depression Stage 1) Those who meet the diagnostic criteria for prediabetes in the "Expert Consensus on Prevention of Type 2 Diabetes in Chinese Adults" in 2014; 2) Conform to the diagnosis of liver qi stagnation syndrome; 3) Age 18-70 years old; 4) Those who have never used diabetes-related drugs before; 5) Those who signed the informed consent form. Inclusion Criteria - Hot Stage 1) According to the 1999 WHO criteria, the newly diagnosed or newly treated patients who meet the diagnostic criteria of early and mid-stage type 2 diabetes, after the screening period (diet control + exercise therapy for 4 weeks), fasting blood glucose = 7.0mmol/L, but fasting blood glucose <13.9 mmol/L, or 2h postprandial blood glucose =11.1mmol/L; and glycosylated hemoglobin =7.0%; 2) In line with the diagnosis of intestinal damp-heat syndrome; 3) Age 18-70 years old; 4) Those who signed the informed consent. Inclusion Criteria - Healthy People 1) Meet the diagnostic criteria of healthy people, and the TCM constitution is judged to be peaceful; 2) Age: 18-70 years old; 3) The blood sugar is within the normal range; 4) Those who signed the informed consent.

Exclusion criteria

Exclusion criteria: Exclusion criteria - depression stage 1) Those who do not meet the diagnostic and inclusion criteria; 2) Those with elevated blood sugar in stress state or with secondary elevated blood sugar; 3) Patients with mental illness; 4) Those taking other hypoglycemic drugs at the same time; 5) Proliferative retinopathy requiring laser treatment; 6) Patients with severe heart, brain, liver and kidney diseases or other serious diseases of the system; 7) Patients with acute cardiovascular and cerebrovascular events or myocardial infarction within 6 months; 8) Those who cannot cooperate with the test due to various reasons; 9) Women who are pregnant, planning to become pregnant or breastfeeding. Exclusion Criteria - Hot Phase 1) Those with diabetes complications as the main symptom, and those with severe heart, lung, liver, kidney, brain and other complications or combined with other serious primary diseases; 2) If the blood pressure is uncontrolled or controlled, the systolic blood pressure is =160mmHg or (and) the diastolic blood pressure is =100mmHg, and the dosage and type of antihypertensive drugs taken cannot be kept stable; 3) Patients with diabetic ketosis, ketoacidosis and severe infection within the past 1 month; 4) mentally ill patients; 5) Women who are pregnant, planning to become pregnant or breastfeeding; 6) Alcohol and/or psychoactive substances, drug abusers and dependents within the past 5 years; 7) According to the judgment of the researcher, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as frequent changes in the working environment and unstable living environment, which are likely to cause loss to follow-up; 8) Patients with impaired liver and kidney function (ALT and AST are greater than 2 times the upper limit of normal, and serum creatinine is greater than the upper limit of normal); 9) Known asymptomatic to hypoglycemia. Exclusion Criteria - Healthy People 1) Those who suffer from diseases of the respiratory system, digestive system, endocrine system, cardiovascular system and other diseases during the diagnosis; 2) mentally ill patients; 3) Women who are pregnant, planning to become pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
metabolomics;ECG;regular bowel movement;Proteomics;Biochemical full item;Islet function (fasting);Urine routine;;metagenomics;blood routine;Islet function (2 hours after meals);2 hours postprandial blood sugar;glycosylated hemoglobin;

Countries

China

Contacts

Public ContactLimin
limin-72114@163.com13261029206

Outcome results

None listed

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