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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
The First Affiliated Hospital of Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Nephropathies focused on measuring Diabetic Kidney Disease

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    July 13, 2021
    Last Updated
    July 26, 2021
    Sponsor
    The First Affiliated Hospital of Xiamen University
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    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

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    Prevention In Community Clinics From Diabetic Kidney Disease

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