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

Exercise Clinical Trial

Official title:

Chief of Nephrology, Professor, Shanghai Pudong Hospital,

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03222726
• Other study ID #: ShanghaiPudongH
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 6, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2020
• Source: Shanghai Pudong Hospital
• Contact: Hui Min Jin, MD
• Phone: +86 13917232915
• Email: hmjgli[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: October 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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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Related Conditions & MeSH terms

• Diabetic Nephropathies
• Exercise

Intervention

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

Locations

Country	Name	City	State
China	Shanghai Pudong Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pudong Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	kidney endpoint	Blood creatinine doubled on baseline, or was evaluated by eGFR and needed for dialysis or transplantation	3-year
Secondary	cardiovascular endpoint	Cardiac failure and acute myocardial infarction were defined as cardiac endpoints	3-year
Secondary	cerebrovascular endpoint	stroke or Cerebral hemorrhage	3 years
Secondary	Retinal progression	The severity of retinopathy was analyzed based on the fundus photographs	3 years