Status:
COMPLETED
Blood Pressure Control Target in Diabetes
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Blood Pressure Control Target in Diabetes
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
This is a multicenter, open-label, parallel-group, randomized controlled trial that will be conducted across mainland China. This trial will test the primary hypothesis of whether an intensive treatme...
Detailed Description
The trial will recruit 12,702 patients from approximately 150 hospitals within the China Diabetes Clinical Research Network. Eligible criteria include men and women aged ≥50 years; type 2 diabetes mel...
Eligibility Criteria
Inclusion
- Men and women aged ≥50 years;
- Diabetes defined as:
- A self-reported previous diagnosis by health care professionals and taking anti-diabetic medications;
- Fasting plasma glucose level of ≥126 mg/dL (7.0 mmol/L). Fasting is defined as no caloric intake for at least 8 hours;
- 2-hour plasma glucose level of ≥200 mg/dL (11.1 mmol/L) during an oral glucose tolerance test. The test should be performed using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water; or
- HbA1c concentration of ≥6.5% (48 mmol/mol);
- Systolic blood pressure
- ≥140 mmHg on 0 medication;
- 130-180 mmHg on 1 medication;
- 130-170 mmHg on up to 2 medications;
- 130-160 mmHg on up to 3 medications; or
- 130-150 mmHg on up to 4 medications;
- Increased risk of cardiovascular disease (one or more of the following):
- Previous history of clinical CVD (≥ 3 months)
- Subclinical CVD within 3 years
- 2 or more CVD risk factors
- Estimated glomerular filtration rate (eGFR) 30-59 ml/min/1.73 m2
Exclusion
- History consistent with type 1 diabetes
- Known secondary cause of hypertension
- One minute standing systolic BP \<110 mmHg
- Arm circumference too large to allow accurate blood pressure measurement with available devices
- Cardiovascular event or procedure or hospitalization for unstable angina within the past 3 months
- Symptomatic heart failure within the past 6 months or left ventricular ejection fraction (by any method) \<35% within the past 6 months
- ALT or AST levels more than twice the upper limit of the normal range or active liver diseases
- Dialysis, kidney transplantation, eGFR \<30 ml/min/1.73 m2, or serum creatinine \>2.0 mg/dl
- Proteinuria
- Previous diagnosis of polycystic kidney disease or glomerulonephritis
- A medical condition likely to limit survival to less than 5 years
- Any factors judged by the clinic team to be likely to limit adherence to interventions
- Failure to obtain informed consent from participant
- Currently participating in another intervention study
- Currently living with another BPROAD participant
- Pregnancy, currently trying to become pregnant, or of child-bearing potential and not using birth control
Key Trial Info
Start Date :
February 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2024
Estimated Enrollment :
12821 Patients enrolled
Trial Details
Trial ID
NCT03808311
Start Date
February 24 2019
End Date
September 15 2024
Last Update
October 23 2024
Active Locations (1)
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1
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025