prediabetes
Conditions
Interventions
Group A:Zhishanfang Granules plus dietary and exercise interventions
Group B:dietary and exercise interventions
Sponsors
The First Affiliated Hospital of Guangdong Pharmaceutical University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Pre-diabetes patients (according to the 2025 ADA Standards of Medical Care in Diabetes: 1) Hemoglobin A1c 5.7–6.4% (39–47 mmol/mol); or 2) Fasting plasma glucose 100 mg/dL (5.6 mmol/L) to 125 mg/dL (6.9 mmol/L) (impaired fasting glucose); or 3) 2-hour plasma glucose in a 75g oral glucose tolerance test (OGTT) 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (impaired glucose tolerance)); (2) Aged =18 years; (3) Able to actively cooperate with treatment including regular follow-up visits and taking the study medication on time; (4) Agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will not be included in the clinical observation: (1) Patients already diagnosed with diabetes mellitus; (2) Patients who have had acute complications within the past month including cerebral hemorrhage hyperosmolar coma myocardial infarction or left ventricular ejection fraction <40% stroke or transient ischemic attack; (3) Patients who have taken antidiabetic medications within the past month or medications affecting glucose metabolism within the past week; (4) Pregnant or breastfeeding women; (5) Patients with severe psychiatric disorders who are unable to cooperate; (6) Patients allergic to any components of Zhishanfang Granules; (7) Any other medical conditions that the investigator believes may pose a risk to the patient or affect the study outcomes or any medical conditions that the investigator deems unsuitable for the study including drug or alcohol abuse that may affect the patient's ability to comply with the protocol or follow-up procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-hour plasma glucose level in an Oral Glucose Tolerance Test (OGTT); | — |
Secondary
| Measure | Time frame |
|---|---|
| postprandial 2-hour insulin;TCM Syndrome Scale of Glycolipid Metabolism; liver function;1-hour plasma glucose level in an Oral Glucose Tolerance Test (OGTT);waist circumference;Cumulative Incidence Rate;BMI; fasting blood sugar;HOMA-IR;heart rate; Lipid complete;Traditional Chinese Medicine tongue signs; blood pressure;The clinical event rate of reversal to normal glycemia or transition to T2DM;TCM Constitution Score;Traditional Chinese Medicine facial signs;HOMA-ß;HOMA-IS;WHR;Traditional Chinese Medicine eye signs;Tongue coating;Urine;urine routine examination;Patient-Reported Outcomes Scale Score for GLMD;postprandial 1-hour insulin;TCM Diagnosis Scale Score for Sub-Health in GLMD;Venous blood;blood routine examination;Risk Screening Scale Score for GLMD;hip circumference;Feces;HbA1c;weight;renal function;fasting insulin; | — |
Countries
China
Contacts
Public ContactGuo Jiao
The First Affiliated Hospital of Guangdong Pharmaceutical University
Outcome results
None listed