The Study of the Internet Monitoring and Analysis of Exercise to Reduce the Complications of Diabetic Kidney Disease
Chief of Nephrology, Professor, Shanghai Pudong Hospital,
1 other identifier
interventional
240
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Shorter than P25 for not_applicable
1 active site
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 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedStudy Start
First participant enrolled
April 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedMarch 17, 2021
April 1, 2020
3 months
July 18, 2017
March 16, 2021
Conditions
Keywords
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 COMPARATOR6000 steps/day or 40,000 steps/week
less-exercise group
OTHERless than 6000 steps/day or 40,000 steps/week
Interventions
less than 6000 steps/day or 40,000 steps/week
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bo Yu
Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- 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
- Shared Documents
- STUDY PROTOCOL, ICF, CSR, ANALYTIC CODE
- Time Frame
- data will become available when paper published in English journal, and for 5 years
study is completed.all data is open in clinicaltrials.gov