Blood Pressure Control for Type 2 Diabetes

NCT03477786 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1500

Last updated 2018-03-26

No results posted yet for this study

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 diagnosed CV events. We set our primary outcome for the prevention of microalbuminuria development. The secondary outcomes include mortality, annual renal function declining rate, and development of cardiovascular events. The recruitment period for the RCT trial is from 2013 Oct to 2019 Dec. In addition, we also intend to continuously follow up all our recruited hypertensive diabetes patients for at least 10 years to observe their clinical outcomes including cardiovascular, renal, retinal outcomes and mortality.

Conditions

Interventions

COMBINATION_PRODUCT

drug adjustment and behavioral modification

anti-hypertension drug prescription by physician and case management by health educator

Sponsors & Collaborators

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Chih-Cheng Hsu, DrPH · National Health Research Institutes, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-28
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Taiwan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03477786 on ClinicalTrials.gov