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A pragmatic, open-label, parallel-group, individually randomized controlled trial evaluating the effectiveness of ACEI/ARB antihypertensive drugs in preventing diabetes among patients with hypertension and prediabetes under community-based population management

A pragmatic, open-label, parallel-group, individually randomized controlled trial evaluating the effectiveness of ACEI/ARB antihypertensive drugs in preventing diabetes among patients with hypertension and prediabetes under community-based population management

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108735
Enrollment
Unknown
Registered
2025-09-04
Start date
2025-09-05
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Hypertension and prediabetes

Interventions

Intervention group (Group A):Monotherapy or combination therapy based on ARB-based (ACEI-based) antihypertensive drugs
Control group (Group B):Non-ARB or ACEI antihypertensive drugs (including diuretics/calcium channel blockers/ß-blockers/a-blockers) as monotherapy or in combination.

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Volunteer to participate in this study and sign the informed consent form; 2. Age >=18 years old; 3. Gender is not limited; 4. Patients who have been diagnosed with hypertension (judged based on clinical diagnosis); 5. Any of the following hypertension conditions: a. Confirmed hypertension without medication; b. Receiving antihypertensive therapy but poor blood pressure control (blood pressure measurement on the same day >=140/90mmHg); 6. Patients with prediabetes, including any of the following: a. Fasting blood glucose was 6.1–7.0 mmol/L; b. Glycated hemoglobin range 5.7%–6.5%; c. 2-hour blood glucose between 7.8–11.1 mmol/L.

Exclusion criteria

Exclusion criteria: 1. Secondary hypertension; 2. Patients with diabetes mellitus (defined as intravenous fasting blood glucose >=7.0 mmol/L, or OGTT blood glucose >=11.1 mmol/L 2 hours after taking sugar, and finally judged according to clinical diagnosis); or glycated hemoglobin value > 6.5%; 3. Those with severe cardiovascular disease (stroke, myocardial infarction, heart failure, etc.) within 3 months; 4. Patients with other serious physical diseases, tumors and other serious diseases; 5. Those who plan to become pregnant within 2 years, or pregnant or lactating women; 6. People who take more than three antihypertensive drugs or those who are currently taking ACEI/ARB drugs at the recommended maximum dose. The specific decision is made by the doctor according to the patient's medication situation. 7. Patients with severe abnormal liver function (ALT/AST> 3 times the upper limit of normal value); 8. Patients with abnormal renal function: eGFR=300 mg/g or urine protein quantitative >=500 mg/24h); 9. Those with obvious cognitive impairment or mental illness; 10. Not suitable for people taking ARB/ACEI antihypertensive drugs, such as: bilateral renal artery stenosis, creatinine >=250 mmol/L or eGFR5.5 mmol/L), angioneurotic edema with ACEIs, left ventricular outflow tract obstruction (such as aortic stenosis, obstructive hypertrophic cardiomyopathy), symptomatic hypotension (systolic blood pressure). 10/µL, urine leukocyte > 10/µL, etc. The specific diagnosis and treatment shall be comprehensively judged by community doctors based on the patient's clinical examination results and symptoms. 16. Other patients who are not suitable for enrollment as assessed by the expert team of the center.

Design outcomes

Primary

MeasureTime frame
Diabetes incidence;

Secondary

MeasureTime frame
Blood sugar;Blood pressure;Blood pressure control rate;Cardiovascular risk score;

Countries

China

Contacts

Public ContactJin Wei/Chao Li

School of Medicine, Xi'an Jiaotong University

lcxjtu_research@163.com+86 29 8265 4212

Outcome results

None listed

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