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Prevention In Community Clinics From Diabetic Kidney Disease

NCT04988581 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1240

Last updated 2021-08-03

No results posted yet for this study

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.

Conditions

  • Diabetic Nephropathies

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xiamen University

    lead OTHER

Principal Investigators

  • Zhibin Li, Ph.D. · The First Affiliated Hospital of Xiamen University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2024-07-31
Completion
2024-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04988581 on ClinicalTrials.gov