The Study of the Internet Monitoring and Analysis of Exercise to Reduce the Complications of Diabetic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03222726
Recruitment Status : Not yet recruiting
First Posted : July 19, 2017
Last Update Posted : April 18, 2018
Information provided by (Responsible Party):
Jin HM, MD, Shanghai Pudong Hospital

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.

Condition or disease Intervention/treatment Phase
Exercise Other: exercise group Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: corhort study
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Chief of Nephrology, Professor, Shanghai Pudong Hospital,
Estimated Study Start Date : October 6, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: exercise group
6000 steps/day or 40,000 steps/week
Other: exercise group
less than 6000 steps/day or 40,000 steps/week
Other Name: less-exercise group

less-exercise group
less than 6000 steps/day or 40,000 steps/week
Other: exercise group
less than 6000 steps/day or 40,000 steps/week
Other Name: less-exercise group

Primary Outcome Measures :
  1. kidney endpoint [ Time Frame: 3-year ]
    Blood creatinine doubled on baseline, or was evaluated by eGFR and needed for dialysis or transplantation

Secondary Outcome Measures :
  1. cardiovascular endpoint [ Time Frame: 3-year ]
    Cardiac failure and acute myocardial infarction were defined as cardiac endpoints

  2. cerebrovascular endpoint [ Time Frame: 3 years ]
    stroke or Cerebral hemorrhage

  3. Retinal progression [ Time Frame: 3 years ]
    The severity of retinopathy was analyzed based on the fundus photographs

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria: Patients with type 2 diabetic nephropathy were diagnosed clinically. Diagnostic criteria: there are many years of history of diabetes, urinary albumin excretion rate of more than 30-300 mg/L, eye exams have diabetic retinopathy, routine urine without red blood cells, double renal morphologic examination is normal (no obstruction after kidney), and excludes the other secondary kidney disease. Age 18-75. Willing to participate in this test.

Exclusion Criteria: Type 1 diabetes, with other systemic diseases such as cancer, liver function damage, severe edema, cardiac insufficiency (grade 3, 4, cardiac function disorder), serious lung disease caused by respiratory insufficiency, pregnancy and lactation women, and could not walk and did not sign the informed consent of the patients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03222726

Contact: Hui Min Jin, MD +86 13917232915
Contact: Bo Yu +86 18918922698

China, Shanghai
Shanghai Pudong Hospital Not yet recruiting
Shanghai, Shanghai, China, 201399
Contact: Hui Min Jin    +86 13917232915   
Contact: Bo Yu    +86 18918922698   
Sub-Investigator: Xiu Hong Yang, MD         
Sub-Investigator: Xiao Li Zhan, MD         
Sub-Investigator: Yan Hong Guo         
Sub-Investigator: Hui Fang Guo         
Sub-Investigator: Dong Chi Zhou         
Sub-Investigator: Qing Yan Qiao         
Sub-Investigator: Li Hua Pan         
Sub-Investigator: Shun Kun Fu         
Sub-Investigator: Li Gang Zhou, MD         
Sub-Investigator: Zhong Sheng Zhu, MD         
Sub-Investigator: Wei Zhong Xiao, MD         
Sponsors and Collaborators
Shanghai Pudong Hospital
Study Director: Bo Yu Hospital

Responsible Party: Jin HM, MD, Professor, Shanghai Pudong Hospital Identifier: NCT03222726     History of Changes
Other Study ID Numbers: ShanghaiPudongH
First Posted: July 19, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: study is completed.all data is open in
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: data will become available when paper published in English journal, and for 5 years

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jin HM, MD, Shanghai Pudong Hospital:
exercise, diabetic kidney disease, complications

Additional relevant MeSH terms:
Kidney Diseases
Diabetic Nephropathies
Urologic Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases