Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04988581 |
| Other study ID # |
KYH2021-032 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
July 2021 |
| Source |
The First Affiliated Hospital of Xiamen University |
| Contact |
Junfeng Zhang, M.D. |
| Phone |
+86-18150090789 |
| Email |
601456564[@]qq.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The overall objective of the proposed randomized trial is to test whether implementation of
intensively integrated care of microvascular risk factors (glycated hemoglobin [HbA1C],
urinary albumin-to-creatinine ratio [ACR], blood pressure [BP], estimated glomerular
filtration rate [eGFR], uric acid [UA] and low-density lipoprotein cholesterol [LDL]) will
improve and reduce diabetic kidney disease events (DKD morbidity and mortality) among
patients with diabetes and additional microvascular risk factors compared to usual care in
public primary care setting (community health service center) in Xiamen, China.
Description:
Most patients with diabetes, which has reached epidemic proportions in China, have multiple
uncontrolled microvascular risk factors due to suboptimal care. Diabetic kidney disease
events (DKD) is one of the most common microvascular complications and has been becoming the
leading cause of end-stage renal disease (ESRD).
The overall objective of the proposed randomized trial is to test whether implementation of
intensively integrated care of microvascular risk factors (glycated hemoglobin [HbA1C],
urinary albumin-to-creatinine ratio [ACR], blood pressure [BP], estimated glomerular
filtration rate [eGFR], uric acid [UA] and low-density lipoprotein cholesterol [LDL]) will
improve and reduce diabetic kidney disease events (DKD morbidity and mortality) among
patients with diabetes and additional microvascular risk factors compared to usual care in
public primary care setting (community health service center) in Xiamen, China.
The Prevention In Community Clinics From Diabetic Kidney Disease (PICK) study is an
open-label randomized controlled trial which will be conducted in one public primary care
setting (Lianqian community health service center) in Xiamen, China. The proposed trial will
recruit 1240 patients with diabetes and additional microvascular risk factors but without DKD
at baseline. Approximately 620 participants will be randomly assigned to the intervention
group and similar participants to the control group.
The intensively integrated care, which will provide a standardized, combined, multi-component
intervention according to clinical guideline treatment for diabetes and comorbidities in a
primary care setting, will be delivered by trained primary care physicians, health managers
and diabetes specialists. Diabetic microvascular risk factors (glycated hemoglobin [HbA1C],
urinary albumin-to-creatinine ratio [ACR], blood pressure [BP], estimated glomerular
filtration rate [eGFR], uric acid [UA] and low-density lipoprotein cholesterol [LDL]) will be
tested every 3 month for the intervention group and clinical treatment decisions based on the
test results will be implemented accordingly when necessary. The intensively integrated care
intervention will last for 36 months. HbA1C, ACR, BP, eGFR, UA, LDL, other variables and
co-morbidities will be measured at baseline and follow-up visits every 3 month. Meanwhile
management of the diabetic microvascular risk factors for the control group will be conducted
as usual.
In Phase 1, the primary outcomes are mean reductions in HbA1C, ACR, BP, eGFR, UA and LDL
levels over the 18-month intervention between intervention and control groups. Net change in
HbA1C, ACR, BP, eGFR, UA and LDL levels will be simultaneously modeled using a scaled
marginal model which allows estimation of a single overall intervention effect.
In Phase 2, the primary outcome is differences in DKD morbidity and mortality over the
36-month intervention between intervention and control groups.
The secondary outcomes are the cumulative incidence rates of albuminuria and renal impairment
over 36-months of intervention.
The proposed trial is designed to provide 80% statistical power to detect a 4% reduction in
the cumulative incidence of DKD at a 2-sided significance level of 0.05. An 90% follow-up
rate is assumed and is taken into consideration in the power calculation.
This implementation research project has a high impact in public health, because it will
generate urgently needed data on an effective, practical, and sustainable intervention
program aimed at reducing DKD burden among diabetes patients in developing countries.
