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

Primary Purpose

Exercise

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
exercise group
Sponsored by
Shanghai Pudong Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Exercise focused on measuring exercise, diabetic kidney disease, complications

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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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.

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Sites / Locations

  • Shanghai Pudong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

exercise group

less-exercise group

Arm Description

6000 steps/day or 40,000 steps/week

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

cardiovascular endpoint
Cardiac failure and acute myocardial infarction were defined as cardiac endpoints
cerebrovascular endpoint
stroke or Cerebral hemorrhage
Retinal progression
The severity of retinopathy was analyzed based on the fundus photographs

Full Information

First Posted
July 18, 2017
Last Updated
March 16, 2021
Sponsor
Shanghai Pudong Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03222726
Brief Title
The Study of the Internet Monitoring and Analysis of Exercise to Reduce the Complications of Diabetic Kidney Disease
Official Title
Chief of Nephrology, Professor, Shanghai Pudong Hospital,
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 6, 2021 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Pudong Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Research target:To explore exercise intervention in patients with diabetic nephropathy (intervention time for 3 years), the events in the primary end point was observed (double serum creatinine, ESRD dialysis) and secondary events (reduced urinary protein and retinopathy progression, cardiovascular events, and cerebrovascular events for all-cause mortality). Major technical programmes: The research object:Clinical diagnosis of type 2 diabetic nephropathy patients. The inclusion criteria: Clinical diagnosis of type 2 diabetic nephropathy patients.Many years 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 being normal, 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. Estimate the sample size: In this study, the incidence of the combined endpoint was 40% in the untreated group, 30% in the treatment group, 10% in the treatment group and 80% in the control group, and 0.05 in bilateral statistical level. The above formulations are calculated by each group of 112 cases; Therefore, the sample size of this study is 120 cases per group. Corhort study: Exercise group (walking 6000 steps or more than 40,000 steps on foot), non-exercise group (walking 6000 steps or less than 40,000 steps on foot). Follow-up examization: Check the routine of morning urine daily, and check the blood sugar, HbA1c, fasting insulin level, kidney function, liver function, electrolyte, blood routine, blood c-reactive protein and blood type B natriuretic peptide per quarter. Kidney endpoint event: The blood creatinine was doubled on baseline, or the eGFR was assessed for end-stage renal disease and required dialysis or transplantation. Cardiovascular endpoint event: During the observation, cardiac failure and acute myocardial infarction were defined as cardiac endpoints Cerebrovascular endpoint event: Hospitalization of cerebral stroke or cerebral hemorrhage is defined as the end of the brain. Retinal progression: The severity of retinopathy was analyzed based on the fundus photographs, according to Early Treatment Diabetic Retinopathy Study (ETDRS)(1. Benefits of Renin-Angiotensin Blockade on Retinopathy in Type 1 Diabetes Vary With Glycemic Control. Diabetes Care 2011; 34:1838-1842。2. Renal and Retinal Effects of Enalapril and Losartan in Type 1 Diabetes. N Eng J Med 2009; 361:40-51). Adverse reactions: The adverse reactions of the movement include collapse, body weakness and muscle soreness are recorded. Internet web system: The urine is monitored outside the general hospital, and The patient urine routine test results were tracked in real time by the external follow-up system of subekang internet web system. Monitor steps:Add patients' buddy feature to WeChat to add the WeChat movement public number to see the number of steps on the WeChat public number.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise
Keywords
exercise, diabetic kidney disease, complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
corhort study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise group
Arm Type
Active Comparator
Arm Description
6000 steps/day or 40,000 steps/week
Arm Title
less-exercise group
Arm Type
Other
Arm Description
less than 6000 steps/day or 40,000 steps/week
Intervention Type
Other
Intervention Name(s)
exercise group
Other Intervention Name(s)
less-exercise group
Intervention Description
less than 6000 steps/day or 40,000 steps/week
Primary Outcome Measure Information:
Title
kidney endpoint
Description
Blood creatinine doubled on baseline, or was evaluated by eGFR and needed for dialysis or transplantation
Time Frame
3-year
Secondary Outcome Measure Information:
Title
cardiovascular endpoint
Description
Cardiac failure and acute myocardial infarction were defined as cardiac endpoints
Time Frame
3-year
Title
cerebrovascular endpoint
Description
stroke or Cerebral hemorrhage
Time Frame
3 years
Title
Retinal progression
Description
The severity of retinopathy was analyzed based on the fundus photographs
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Min Jin, MD
Phone
+86 13917232915
Email
hmjgli@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Bo Yu
Phone
+86 18918922698
Email
yubo120@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Yu
Organizational Affiliation
Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Pudong Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201399
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Min Jin
Phone
+86 13917232915
Email
hmjgli@163.com
First Name & Middle Initial & Last Name & Degree
Bo Yu
Phone
+86 18918922698
Email
yubo120@hotmail.com
First Name & Middle Initial & Last Name & Degree
Xiu Hong Yang, MD
First Name & Middle Initial & Last Name & Degree
Xiao Li Zhan, MD
First Name & Middle Initial & Last Name & Degree
Yan Hong Guo
First Name & Middle Initial & Last Name & Degree
Hui Fang Guo
First Name & Middle Initial & Last Name & Degree
Dong Chi Zhou
First Name & Middle Initial & Last Name & Degree
Qing Yan Qiao
First Name & Middle Initial & Last Name & Degree
Li Hua Pan
First Name & Middle Initial & Last Name & Degree
Shun Kun Fu
First Name & Middle Initial & Last Name & Degree
Li Gang Zhou, MD
First Name & Middle Initial & Last Name & Degree
Zhong Sheng Zhu, MD
First Name & Middle Initial & Last Name & Degree
Wei Zhong Xiao, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
study is completed.all data is open in clinicaltrials.gov
IPD Sharing Time Frame
data will become available when paper published in English journal, and for 5 years

Learn more about this trial

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

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