Prevention In Community Clinics From Diabetic Kidney Disease (PICK)

July 26, 2021 updated by: The First Affiliated Hospital of Xiamen University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

1240

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Junfeng Zhang, M.D.
  • Phone Number: +86-18150090789
  • Email: 601456564@qq.com

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensively Integrated Care of Microvascular Risk Factors
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])
Other: Intensively integrated care of microvascular risk factors in the intervention 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.
No Intervention: Usual Care of Microvascular Risk Factors
Usual care among patients with diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Phase 1
Time Frame: 18 months
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.
18 months
Phase 2
Time Frame: 36 months
In Phase 2, the primary outcome is differences in DKD morbidity and mortality over the 36-month intervention between intervention and control groups.
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The secondary outcomes
Time Frame: 36 months
The secondary outcomes are the cumulative incidence rates of albuminuria and renal impairment over the 36-month individually over 36-months of intervention.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Zhibin Li, Ph.D., The First Affiliated Hospital of Xiamen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 1, 2021

Primary Completion (Anticipated)

July 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 26, 2021

First Posted (Actual)

August 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYH2021-032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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