NCT03477786

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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2013

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 26, 2018

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

March 26, 2018

Status Verified

March 1, 2018

Enrollment Period

10.2 years

First QC Date

March 11, 2018

Last Update Submit

March 18, 2018

Conditions

Type 2 Diabetes MellitusHypertension

Outcome Measures

Primary Outcomes (1)

  • development of microalbuminuria

    indicator of microalbuminuria: urine ACR

    up to 10 years

Secondary Outcomes (3)

  • mortality

    up to 10 years

  • annual renal function declining rate

    up to 10 years

  • development of cardiovascular events

    up to 10 years

Study Arms (2)

tight BP

ACTIVE COMPARATOR

Interventions: anti-hypertension drug prescription by physician and case management by health educator. Blood pressure is targeted at 120/80 mmHg in the tight BP control group.

Combination Product: drug adjustment and behavioral modification

usual BP

PLACEBO COMPARATOR

Interventions: The physicians follow their usual care patterns to prescribe anti-HT drugs. Blood pressure is targeted at \< 140/90 mmHg in the usual BP control group.

Combination Product: drug adjustment and behavioral modification

Interventions

drug adjustment and behavioral modificationCOMBINATION_PRODUCT

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

tight BPusual BP

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • type 2 DM with hypertension

You may not qualify if:

  • 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
  • unstable BP (SBP\>160 or DBP\>100)
  • unstable glycemic control (HbA1c\>10%)
  • K\>5.0 meq/L

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

Min-Sheng General Hospital

Taoyuan District, Taiwan

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hypertension

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Chih-Cheng Hsu, DrPH

    National Health Research Institutes, Taiwan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chih-Cheng Hsu, DrPH

CONTACT

886-37-246166cch@nhri.org.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2018

First Posted

March 26, 2018

Study Start

October 28, 2013

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

March 26, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
after the trial is completed
Access Criteria
contact the principal investigator for data application

Locations

TW(2)