The Study of the Internet Monitoring and Analysis of Exercise to Reduce the Complications of Diabetic Kidney Disease
Keywords
Abstract
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.
Dates
Last Verified: | 03/31/2018 |
First Submitted: | 07/17/2017 |
Estimated Enrollment Submitted: | 07/17/2017 |
First Posted: | 07/18/2017 |
Last Update Submitted: | 04/16/2018 |
Last Update Posted: | 04/17/2018 |
Actual Study Start Date: | 10/05/2018 |
Estimated Primary Completion Date: | 06/30/2021 |
Estimated Study Completion Date: | 09/30/2021 |
Condition or disease
Intervention/treatment
Other: exercise group
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Active Comparator: exercise group 6000 steps/day or 40,000 steps/week | |
Other: less-exercise group less than 6000 steps/day or 40,000 steps/week |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
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. - |
Outcome
Primary Outcome Measures
1. kidney endpoint [3-year]
Secondary Outcome Measures
1. cardiovascular endpoint [3-year]
2. cerebrovascular endpoint [3 years]
3. Retinal progression [3 years]