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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05479331
Other study ID # sarcopenia
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date December 31, 2021

Study information

Verified date December 2019
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study explores the risk factors for sarcopenia in patients with chronic kidney disease and the effects of sarcopenia on cardiovascular disease. Treatment of sarcopenia and cardiovascular complications provides a basis for improving the quality of life and survival of patients with chronic kidney disease.


Description:

Sarcopeniais a syndrome characterized by the loss of skeletal muscle mass, muscle strength, and muscle dysfunction. The high incidence of sarcopenia in patients with chronic kidney disease (CKD) is strongly associated with poor quality of life, cardiovascular events, and increased all-cause mortality. At present, the cause of sarcopenia in patients with CKD is still unclear, and factors such as inflammation, malnutrition, and hormone metabolism disorders may affect the occurrence and development of sarcopenia. This topic explores the risk factors of sarcopenia in patients with chronic kidney disease and the correlation between sarcopenia and the risk of cardiovascular disease, and provides a basis for the prevention and treatment of sarcopenia and cardiovascular complications, with a view to improving the prognosis of CKD patients.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date December 31, 2021
Est. primary completion date March 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Patients presented by the Nephrology Center during August 2019 and March 2021 - Age 18-75 years; - Patients with CKD2 or above (eGFR=60 ml/(min 1.73m2) Exclusion Criteria: - There are contraindications to bioelectrical impedance spectroscopy (BIS) . examination, such as amputation, metal implants in the body, etc.; - Complicated with other serious diseases, such as malignant tumors, cirrhosis, systemic infections, etc.

Study Design


Locations

Country Name City State
China Baoshan Site of Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Epicardial adipose tissue measured by ultrasound color doppler EAT is defined as a fat depot that exists on the surface of the myocardium,which plays a detrimental role in our health. EAT would be measured by ultrasound color doppler. the day when being recruited
Primary Intima-media thickness measured by ultrasound color doppler IMT of carotid arteries, as assessed noninvasively by carotid ultrasonography, is a useful measure of preclinical atherosclerosis. Carotid IMT has been found to predict future risk of cardiovascular disease.IMT would be measured by ultrasound color doppler. the day when being recruited
Secondary Baseline demographic, clinical and laboratory characteristics Demographic characteristics include age, sex, height, body mass, blood pressure, primary disease, and comorbidities. BMI = the square of body weight/height (kg/m2). Patient comorbidities were assessed using the Charlson comorbidity Index (CCI). Subjective global assessment (SGA) was used to assess the nutritional status of patients. Laboratory characteristics include sALB,Pre-alb,hs-CRP,TC,TAG,LDL-C,HDL-C,PG ,HbA1c ,creatinine,BNP,iPTH,etc. the day when being recruited
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