Blood Pressure Control for Type 2 Diabetes

Hypertension Clinical Trial

— BM4DM  

Official title:

Blood Pressure Control to Reduce Renal Risk for Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03477786
• Other study ID #: PH-107-PP-21
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2018
• Last updated: March 18, 2018
• Start date: October 28, 2013
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2018
• Source: National Health Research Institutes, Taiwan
• Contact: Chih-Cheng Hsu, DrPH
• Phone: 886-37-246166
• Email: cch[@]nhri.org.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Hypertension
• Type 2 Diabetes Mellitus

Intervention

Combination Product:
• drug adjustment and behavioral modification
anti-hypertension drug prescription by physician and case management by health educator

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University Hospital	Kaohsiung
Taiwan	Min-Sheng General Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	development of microalbuminuria	indicator of microalbuminuria: urine ACR	up to 10 years
Secondary	mortality	all-cause mortality and CV-specific mortality	up to 10 years
Secondary	annual renal function declining rate	indicator of renal function: eGFR assessed by CKD-EPI formula	up to 10 years
Secondary	development of cardiovascular events	cardiovascular events include MI, heart failure, and stroke	up to 10 years