Prevention In Community Clinics From Diabetic Kidney Disease (PICK)
Primary Purpose
Diabetic Nephropathies
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intensively integrated care of microvascular risk factors in the intervention group
Sponsored by
About this trial
This is an interventional prevention trial for Diabetic Nephropathies focused on measuring Diabetic Kidney Disease
Eligibility Criteria
Inclusion Criteria:
- Type 2 Diabetes patients
- Men or women aged 30-75 years who received primary care from the Lianqian clinics in Xiamen, China
- Patients with at least one 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]) .
Exclusion Criteria:
- Diabetic Kidney Disease
- Patients with heart failure, or receiving hemodialysis, or with contraindications to metformin or statin treatments
- Women who are pregnant or plan to become pregnant
- Patients who cannot be followed for 36 months
- Patients who are unwilling or unable to give informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intensively Integrated Care of Microvascular Risk Factors
Usual Care of Microvascular Risk Factors
Arm Description
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])
Usual care among patients with diabetes
Outcomes
Primary Outcome Measures
Phase 1
In Phase 1, the primary outcomes are mean changes in HbA1C, ACR, BP, eGFR, UA and LDL levels over the 18-month intervention between intervention and control groups.
Phase 2
In Phase 2, the primary outcome is differences in DKD morbidity and mortality over the 36-month intervention between intervention and control groups.
Secondary Outcome Measures
The secondary outcomes
The secondary outcomes are the cumulative incidence rates of albuminuria and renal impairment over the 36-month individually over 36-months of intervention.
Full Information
NCT ID
NCT04988581
First Posted
July 13, 2021
Last Updated
July 26, 2021
Sponsor
The First Affiliated Hospital of Xiamen University
1. Study Identification
Unique Protocol Identification Number
NCT04988581
Brief Title
Prevention In Community Clinics From Diabetic Kidney Disease
Acronym
PICK
Official Title
Effectiveness of Intensively Integrated Care of Microvascular Risk Factors to Prevent Diabetic Kidney Disease Incidences in Community Clinics in Xiamen, China: An Open-label Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2021 (Anticipated)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Xiamen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathies
Keywords
Diabetic Kidney Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intensively Integrated Care of Microvascular Risk Factors
Arm Type
Experimental
Arm Description
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])
Arm Title
Usual Care of Microvascular Risk Factors
Arm Type
No Intervention
Arm Description
Usual care among patients with diabetes
Intervention Type
Other
Intervention Name(s)
Intensively integrated care of microvascular risk factors in the intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Phase 1
Description
In Phase 1, the primary outcomes are mean changes in HbA1C, ACR, BP, eGFR, UA and LDL levels over the 18-month intervention between intervention and control groups.
Time Frame
18 months
Title
Phase 2
Description
In Phase 2, the primary outcome is differences in DKD morbidity and mortality over the 36-month intervention between intervention and control groups.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
The secondary outcomes
Description
The secondary outcomes are the cumulative incidence rates of albuminuria and renal impairment over the 36-month individually over 36-months of intervention.
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type 2 Diabetes patients
Men or women aged 30-75 years who received primary care from the Lianqian clinics in Xiamen, China
Patients with at least one 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]) .
Exclusion Criteria:
Diabetic Kidney Disease
Patients with heart failure, or receiving hemodialysis, or with contraindications to metformin or statin treatments
Women who are pregnant or plan to become pregnant
Patients who cannot be followed for 36 months
Patients who are unwilling or unable to give informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junfeng Zhang, M.D.
Phone
+86-18150090789
Email
601456564@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Changqin Liu, M.D.
Phone
+86-592-2137610
Email
liuchangqin@xmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhibin Li, Ph.D.
Organizational Affiliation
The First Affiliated Hospital of Xiamen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Prevention In Community Clinics From Diabetic Kidney Disease
We'll reach out to this number within 24 hrs