Status:
UNKNOWN
Blood Pressure Control for Type 2 Diabetes
Lead Sponsor:
National Health Research Institutes, Taiwan
Conditions:
Type 2 Diabetes Mellitus
Hypertension
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The BP4DM study was initiated as a prospective randomized controlled trial to investigate the renal protection effect for tight blood pressure control for Taiwanese T2DM patients without previously di...
Detailed Description
The evidence from previous literature shows importance of the blood pressure control in T2DM. About 20% (16-29%) reduction in microalbuminuria development can be reached by continuously lowering blood...
Eligibility Criteria
Inclusion
- Inclusion Criteria (for both RCT trial and observational cohort study):
- type 2 DM with hypertension
- Exclusion Criteria (for both RCT trial and observational cohort study):
- ACR\>300 mg/g
- prior history of severe CV events (e.g., MI, stroke, heart failure\>NYHA functional class III)
- dialysis, blindness, amputation, liver cirrhosis, cancer under active treatment
- pregnant women
- proteinuria which is unrelated with diabetes
- urinary tract stone \> 0.5 cm
- Stricter Exclusion Criteria (for RCT trial only):
- unstable BP (SBP\>160 or DBP\>100)
- unstable glycemic control (HbA1c\>10%)
- K\>5.0 meq/L
Exclusion
Key Trial Info
Start Date :
October 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03477786
Start Date
October 28 2013
End Date
December 31 2023
Last Update
March 26 2018
Active Locations (2)
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1
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
2
Min-Sheng General Hospital
Taoyuan District, Taiwan