Blood Pressure Control Target in Diabetes

Not Applicable

Active, not recruiting

• Conditions: Blood Pressure Control Target in Diabetes

• Registration Number: NCT03808311
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Men and women aged =50 years;<br><br> 2. Diabetes defined as:<br><br> - A self-reported previous diagnosis by health care professionals and taking<br> anti-diabetic medications;<br><br> - Fasting plasma glucose level of =126 mg/dL (7.0 mmol/L). Fasting is defined as<br> no caloric intake for at least 8 hours;<br><br> - 2-hour plasma glucose level of =200 mg/dL (11.1 mmol/L) during an oral glucose<br> tolerance test. The test should be performed using a glucose load containing<br> the equivalent of 75 g anhydrous glucose dissolved in water; or<br><br> - HbA1c concentration of =6.5% (48 mmol/mol);<br><br> 3. Systolic blood pressure<br><br> -=140 mmHg on 0 medication;<br><br> - 130-180 mmHg on 1 medication;<br><br> - 130-170 mmHg on up to 2 medications;<br><br> - 130-160 mmHg on up to 3 medications; or<br><br> - 130-150 mmHg on up to 4 medications;<br><br> 4. Increased risk of cardiovascular disease (one or more of the following):<br><br> - Previous history of clinical CVD (= 3 months)<br><br> - Subclinical CVD within 3 years<br><br> - 2 or more CVD risk factors<br><br> - Estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2<br><br>Exclusion Criteria:<br><br> 1. History consistent with type 1 diabetes<br><br> 2. Known secondary cause of hypertension<br><br> 3. One minute standing systolic BP <110 mmHg<br><br> 4. Arm circumference too large to allow accurate blood pressure measurement with<br> available devices<br><br> 5. Cardiovascular event or procedure or hospitalization for unstable angina within the<br> past 3 months<br><br> 6. Symptomatic heart failure within the past 6 months or left ventricular ejection<br> fraction (by any method) <35% within the past 6 months<br><br> 7. ALT or AST levels more than twice the upper limit of the normal range or active<br> liver diseases<br><br> 8. Dialysis, kidney transplantation, eGFR <30 ml/min/1.73 m2, or serum creatinine >2.0<br> mg/dl<br><br> 9. Proteinuria<br><br> 10. Previous diagnosis of polycystic kidney disease or glomerulonephritis<br><br> 11. A medical condition likely to limit survival to less than 5 years<br><br> 12. Any factors judged by the clinic team to be likely to limit adherence to<br> interventions<br><br> 13. Failure to obtain informed consent from participant<br><br> 14. Currently participating in another intervention study<br><br> 15. Currently living with another BPROAD participant<br><br> 16. Pregnancy, currently trying to become pregnant, or of child-bearing potential and<br> not using birth control

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Major cardiovascular events

Secondary Outcome Measures

Name	Time	Method
A composite of the primary outcome and all-cause mortality;Macrovascular outcome;Major coronary artery diseases;Total stroke;Heart failure;Cardiovascular death;Total mortality;Cognitive function;Health related quality of life;Kidney outcomes