NCT04988581

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2021

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2021

Completed
19 days until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

3 years

First QC Date

July 13, 2021

Last Update Submit

July 26, 2021

Conditions

Diabetic Nephropathies

Keywords

Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (2)

  • 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.

    18 months

  • 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.

    36 months

Secondary Outcomes (1)

  • The secondary outcomes

    36 months

Study Arms (2)

Intensively Integrated Care of Microvascular Risk Factors

EXPERIMENTAL

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

Usual Care of Microvascular Risk Factors

NO INTERVENTION

Usual care among patients with diabetes

Interventions

Intensively integrated care of microvascular risk factors in the intervention groupOTHER

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.

Intensively Integrated Care of Microvascular Risk Factors

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 \[LDL\]) .

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Zhibin Li, Ph.D.

    The First Affiliated Hospital of Xiamen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Junfeng Zhang, M.D.

CONTACT

+86-18150090789601456564@qq.com

Changqin Liu, M.D.

CONTACT

+86-592-2137610liuchangqin@xmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2021

First Posted

August 3, 2021

Study Start

August 1, 2021

Primary Completion

July 31, 2024

Study Completion

December 31, 2024

Last Updated

August 3, 2021

Record last verified: 2021-07