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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200001
        • Baoshan Site of Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
non-sarcopenia
CKD patients with non-sarcopenia

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiao Tong University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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