Blood Pressure Control for Type 2 Diabetes

NCT ID: NCT03477786

Last Updated: 2018-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-28
• Study Completion Date: 2023-12-31

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.

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 pressure level from 154/87 mmHg to 144/82 mmHg (the UKPDS), to 134.7/74.8 mmHg (the ADVANCE study), and even to 119.3/64.4 mmHg (the ACCORD study). However, several limitations are also inherent in the above well-known studies. First, most of the recruited participants previous trials were Caucasians. Although 3293 Chinese patients were recruited in the ADVANCE study, they only accounted for 29.6% of total enrollees in that trial. The representative of Asian population is inadequate. There is also lack of domestic evidence-based guideline designated for Taiwanese T2DM patients in optimizing their blood pressure control. In addition, some characteristics in Asian T2DM population are different from what have been observed in the Caucasian T2DM patients. For example, there is BMI discrepancy between T2DM in Western and Eastern countries, more ACEi/ARB side effects (e.g., cough) observed in Asian population, and the possible difference in CKD/ESRD incidence in T2DM between different ethnic groups.

Moreover, the enrollees in most well-known trials (e.g., ADVANCE and ACCORD studies) were those who suffered from at least one cardiovascular risk factor for secondary prevention. To our best knowledge, there is no study designed to evaluate effectiveness of blood pressure control for T2DM patients without previous CV events. Therefore, we initiated 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 to partly respond to the urgent need for this society in solving the huge burden caused by the high incidence and prevalence of diabetic nephropathy in Taiwan.

The study includes two parts: (1) a RCT trial, (2) an observational cohort study. The recruitment period of this study is from 2013 Oct to 2019 Dec. The RCT trial will be ended in 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 (the part of the observational cohort study).

Conditions

Type 2 Diabetes Mellitus; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

tight BP

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.

Group Type: ACTIVE_COMPARATOR

drug adjustment and behavioral modification

Intervention Type: COMBINATION_PRODUCT

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

usual BP

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.

Group Type: PLACEBO_COMPARATOR

drug adjustment and behavioral modification

Intervention Type: COMBINATION_PRODUCT

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

Interventions

drug adjustment and behavioral modification

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

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

• type 2 DM with hypertension

Exclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Health Research Institutes, Taiwan

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chih-Cheng Hsu, DrPH

Role: PRINCIPAL_INVESTIGATOR

National Health Research Institutes, Taiwan

Locations

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status: RECRUITING

Min-Sheng General Hospital

Taoyuan District, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chih-Cheng Hsu, DrPH

Role: CONTACT

cch@nhri.org.tw

886-37-246166 ext. 36336

Facility Contacts

Kun-Der Lin, PhD

Role: primary

Chih-Cheng Hsu

Role: primary

cch@nhri.org.tw

886-37-246166 ext. 36336

Other Identifiers

PH-107-PP-21

Identifier Type: -

Identifier Source: org_study_id