NCT03222726

Brief Summary

Microvascular complications are a major complication of diabetes.Diabetic microvascular complications can not only lead to chronic kidney disease and retinopathy, but also affect the quality of life of patients with diabetic nephropathy, which can lead to the death of diabetic patients.Due to diabetes patient survival for decades, in spite of more than 90% of time is a life outside the hospital, so the analysis of the effect of outside risk factors for complications of hospital and progress, and to find effective intervention measures is of great significance for the prevention and control of diabetic microvascular complications.Therefore, we use of advanced Internet technology, and analysis of large data algorithms, and try to keep track of routine indicators such as the patient's urine in real time in patients' families. This topic mainly observe movement (step 6000 steps per day or 6000 / week) in patients with type 2 diabetic kidney disease microvascular end point events, provide the basis for prevention and control of diabetes kidney complications, clinical significance and treatment prospects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2017

Completed
3.7 years until next milestone

Study Start

First participant enrolled

April 6, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

March 17, 2021

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

July 18, 2017

Last Update Submit

March 16, 2021

Conditions

Keywords

exercise, diabetic kidney disease, complications

Outcome Measures

Primary Outcomes (1)

  • kidney endpoint

    Blood creatinine doubled on baseline, or was evaluated by eGFR and needed for dialysis or transplantation

    3-year

Secondary Outcomes (3)

  • cardiovascular endpoint

    3-year

  • cerebrovascular endpoint

    3 years

  • Retinal progression

    3 years

Study Arms (2)

exercise group

ACTIVE COMPARATOR

6000 steps/day or 40,000 steps/week

Other: exercise group

less-exercise group

OTHER

less than 6000 steps/day or 40,000 steps/week

Other: exercise group

Interventions

less than 6000 steps/day or 40,000 steps/week

Also known as: less-exercise group
exercise groupless-exercise group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, 201399, China

Location

MeSH Terms

Conditions

Motor ActivityDiabetic Nephropathies

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bo Yu

    Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: corhort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2017

First Posted

July 19, 2017

Study Start

April 6, 2021

Primary Completion

July 1, 2021

Study Completion

October 1, 2021

Last Updated

March 17, 2021

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

study is completed.all data is open in clinicaltrials.gov

Shared Documents
STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
Time Frame
data will become available when paper published in English journal, and for 5 years

Locations