Prediabetes
Conditions
Interventions
Experimental group:Chiglitazar Sodium 48 mg qd + Basic Lifestyle Intervention
Control group:Placebo qd + Basic Lifestyle Intervention
Sponsors
Pengzhou People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Meets the diagnostic criteria for prediabetes; 2.Meets the diagnostic criteria for obesity/overweight; 3.Age between 18 and 70 years (inclusive); 4.Has given informed consent and signed the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Type 1 diabetes mellitus; 2.Prior treatment with oral or injectable hypoglycemic agents (including insulin and traditional Chinese medicine) before the screening period; 3. Refractory hypertension [defined as blood pressure remaining uncontrolled after more than 1 month of treatment with a reasonable and tolerable maximum dose of 3 or more antihypertensive agents (including diuretics) based on lifestyle modification, or requiring 4 or more antihypertensive agents to achieve adequate blood pressure control]; 4.Triglycerides (TG) > 500 mg/dL (5.65 mmol/L); 5.Currently receiving fibrate therapy; 6.History of acute diabetic complications such as diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, or hypoglycemia, or chronic diabetic complications such as retinopathy, diabetic nephropathy, or diabetic neuropathy; 7.Transient ischemic attack, cerebrovascular accident, or unstable angina within the past 6 months; 8.History of myocardial infarction, or history of coronary angioplasty or coronary artery bypass grafting; 9. Cardiac insufficiency (NYHA Class III/IV), or electrocardiographic evidence of left ventricular hypertrophy, or severe arrhythmia; 10.Hepatic diseases such as cirrhosis, active hepatitis, or ALT/AST levels greater than 3 times the upper limit of normal; 11.Moderate to severe renal impairment [eGFR < 15 mL/(min·1.73m^2)]; 12.Malignancy within the past 5 years (except basal cell carcinoma); 13.Current or prior treatment with agents that may alter glucose metabolism, including but not limited to diuretics, hormones (adrenocortical hormones or steroids), or beta-blockers; 14.Diseases affecting glucose metabolism, including but not limited to active hepatitis, hyperthyroidism, or pheochromocytoma; 15.Edema; 16. Alcohol or illicit drug addiction; 17. Participation in another clinical trial of investigational drugs within 3 months prior to screening; 18.Pregnant or lactating women, or women of childbearing potential who are unable or unwilling to use adequate contraception; 19. Subjects deemed unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fasting plasma glucose;2-hour postprandial plasma glucose;Glycated Hemoglobin; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fasting insulin;C-reactive protein;Fasting C-peptide;Gut microbiota;Urinalysis;Blood lipid profile;Interleukin?6; | — |
Countries
China
Contacts
Public ContactJun Liu
Pengzhou People's Hospital
Outcome results
None listed