SarcopeniaNCT05479331
The Relationship Between Sarcopenia and Cardiovascular Disease in Chronic Kidney Disease and the Risk Involved.
An observational study of Sarcopenia and CKD, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sarcopenia, CKD, Cardiovascular Diseases
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with chronic kidney disease
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Baoshan Site of Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200001
About this study
Official title: 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.
Read the 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.
- Conditions
- Sarcopenia, CKD, Cardiovascular Diseases
- Medical subject headings
- Sarcopenia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: the day when being recruited
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.
Measured: the day when being recruited
Secondary outcomes (1)
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.
Measured: the day when being recruited
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start1 Jan 2020
- Primary completion31 Mar 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Na Jiang, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jiangzi Yuan, MD, Study director, Baoshan Site of Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479331
- Sponsor's protocol ID
- sarcopenia
- Status last verified
- Dec 2019
- First submitted
- 27 Jul 2022
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Sarcopenia and Cardiovascular Disease in Chronic Kidney Disease Stage 3 or Higher and the Risk Involved.
- ClinicalTrials.gov ID
- NCT05479331
- Acronym / sponsor ID
- sarcopenia
- Conditions
- Sarcopenia, CKD, Cardiovascular Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with chronic kidney disease
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
1 secondary outcome
Baseline demographic, clinical and laboratory characteristics
Time frame: the day when being recruited
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiangzi Yuan, MD study director
Baoshan Site of Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and CKD, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epicardial adipose tissue measured by ultrasound color doppler (time frame: the day when being recruited). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2022.