ExerciseNCT03222726
The Study of the Internet Monitoring and Analysis of Exercise to Reduce the Complications of Diabetic Kidney Disease
A study testing exercise group in people with Exercise, run by Shanghai Pudong Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Exercise
- What is being tested?
- exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2021to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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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Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399
Hui Min Jin, +86 13917232915, hmjgli@163.com
Bo Yu, +86 18918922698, yubo120@hotmail.com
About this study
Official title: Chief of Nephrology, Professor, Shanghai Pudong Hospital,
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.
Read the 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.
- Conditions
- Exercise
- Being tested
- exercise group
- Keywords
- exercise, diabetic kidney disease, complications
- Medical subject headings
- Motor Activity, Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise groupOther
Also called less-exercise group
less than 6000 steps/day or 40,000 steps/week
| Study group | Role | What they receive |
|---|---|---|
| exercise group | Active comparator | 6000 steps/day or 40,000 steps/week Receives: Other: exercise group |
| less-exercise group | Other | less than 6000 steps/day or 40,000 steps/week Receives: Other: exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
kidney endpoint
Blood creatinine doubled on baseline, or was evaluated by eGFR and needed for dialysis or transplantation
Measured: 3-year
Secondary outcomes (3)
cardiovascular endpoint
Cardiac failure and acute myocardial infarction were defined as cardiac endpoints
Measured: 3-year
cerebrovascular endpoint
stroke or Cerebral hemorrhage
Measured: 3 years
Retinal progression
The severity of retinopathy was analyzed based on the fundus photographs
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2017
- Study start6 Apr 2021 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- corhort study
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pudong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin HM, MD, Shanghai Pudong Hospital
- Investigators
- Bo Yu, Study director, Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03222726
- Sponsor's protocol ID
- ShanghaiPudongH
- Status last verified
- Apr 2020
- First submitted
- 18 Jul 2017
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study is completed.all data is open in clinicaltrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chief of Nephrology, Professor, Shanghai Pudong Hospital,
- ClinicalTrials.gov ID
- NCT03222726
- Acronym / sponsor ID
- ShanghaiPudongH
- Conditions
- Exercise
- Keywords
- exercise, diabetic kidney disease, complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Shanghai Pudong HospitalUniversity, hospital or other
- Study start
- 6 Apr 2021 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 19 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- corhort study
| Arm | Type | Receives |
|---|---|---|
| exercise group | Active comparator | Other: exercise group6000 steps/day or 40,000 steps/week |
| less-exercise group | Other | Other: exercise groupless than 6000 steps/day or 40,000 steps/week |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise groupAlso: less-exercise groupless than 6000 steps/day or 40,000 steps/week | Other | exercise group, less-exercise group |
Primary outcome
kidney endpoint
Time frame: 3-year
Blood creatinine doubled on baseline, or was evaluated by eGFR and needed for dialysis or transplantation
3 secondary outcomes
cardiovascular endpoint
Time frame: 3-year
cerebrovascular endpoint
Time frame: 3 years
Retinal progression
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Individual participant dataSharing planned: Yes. study is completed.all data is open in clinicaltrials.gov
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Yu study director
Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise group in people with Exercise, run by Shanghai Pudong Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Min Jin, MD (+86 13917232915, hmjgli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
kidney endpoint (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.