- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05479331
The Relationship Between Sarcopenia and Cardiovascular Disease in Chronic Kidney Disease and the Risk Involved.
July 28, 2022 updated by: Na Jiang, Shanghai Jiao Tong University School of Medicine
The Relationship Between Sarcopenia and Cardiovascular Disease in Chronic Kidney Disease Stage 3 or Higher and the Risk Involved.
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Shanghai
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Shanghai, Shanghai, China, 200001
- Baoshan Site of Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients with chronic kidney disease
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Other
Cohorts and Interventions
Group / Cohort |
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sarcopenia
CKD patients with sarcopenia, meeting the following two criteria (1) male LTI (lean tissue index)< 7.0 kg/m2, female LTI < 5.7 kg/m2; (2) Male HGS)(handgrip strength < 26 kg, female HGS < 18 kg.
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non-sarcopenia
CKD patients with non-sarcopenia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Epicardial adipose tissue measured by ultrasound color doppler
Time Frame: the day when being recruited
|
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
|
Intima-media thickness measured by ultrasound color doppler
Time Frame: the day when being recruited
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline demographic, clinical and laboratory characteristics
Time Frame: the day when being recruited
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jiangzi Yuan, MD, Baoshan Site of Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2020
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
July 27, 2022
First Submitted That Met QC Criteria
July 27, 2022
First Posted (Actual)
July 29, 2022
Study Record Updates
Last Update Posted (Actual)
August 1, 2022
Last Update Submitted That Met QC Criteria
July 28, 2022
Last Verified
December 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sarcopenia
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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