Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease
NCT ID: NCT04515342
Last Updated: 2024-04-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
140 participants
OBSERVATIONAL
2021-03-10
2026-01-01
Brief Summary
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Detailed Description
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Sarcopenia is known to occur in patients with chronic kidney disease, but whether, and if so, how this differs from the incidence in patients without kidney disease has not previously been described.
Patients with chronic kidney disease have a 3 times higher risk of bone fracture compared to the Danish background population, and they also have an increased risk of falls.
The association between sarcopenia, risk of falls and osteoporosis in patients with kidney disease is until now sparsely described, and because of this, the investigators want to explore this further in this cross-sectional study.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Participants
This is a cross-sectional study involving approximately 150 patients. They undergo a physical examination, fill out a questionnaire, have blood samples drawn, undergo a Dual Energy X-ray Absorptiometry (DXA) scan and different physical procedures to assess muscle strength and muscle function.
DXA
Each participant will undergo one DXA scan
Muscle strength and function assessment
Each patient will have their muscle strength and function assessed with the measurements of handgrip strength, 10 m gait speed and a 30 s sit-to-stand test. They will also fill out a questionnaire assessing Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F questionnaire).
Blood samples
Each patient will undergo a physical examination and also deliver blood samples.
Interventions
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DXA
Each participant will undergo one DXA scan
Muscle strength and function assessment
Each patient will have their muscle strength and function assessed with the measurements of handgrip strength, 10 m gait speed and a 30 s sit-to-stand test. They will also fill out a questionnaire assessing Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F questionnaire).
Blood samples
Each patient will undergo a physical examination and also deliver blood samples.
Eligibility Criteria
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Inclusion Criteria
* Chronic kidney disease stage 4-5 not on dialysis (nonD) (corresponding to an estimated glomerular filtration rate (eGFR) ≤30 ml/min based on Kidney Disease Improving Global Outcomes (KDIGO) definition and not on dialysis)
Exclusion Criteria
* Immobilized/hospitalized for more than 1 week within the last 6 weeks
* Active treatment with growth hormone or sex hormone
* Known muscle disease
* The lack of ability to speak or understand Danish
* The lack of ability to give an informed consent
* The lack of ability to participate in a clinical study based on the assessment by the local investigator
20 Years
120 Years
ALL
No
Sponsors
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Odense University Hospital
OTHER
Herlev Hospital
OTHER
Responsible Party
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Ditte Hansen
Associate professor, MD, PhD
Principal Investigators
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Ditte Hansen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, Herlev and Gentofte Hospital
Locations
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Herlev and Gentofte Hospital, Herlev Hospital
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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Suetta C, Haddock B, Alcazar J, Noerst T, Hansen OM, Ludvig H, Kamper RS, Schnohr P, Prescott E, Andersen LL, Frandsen U, Aagaard P, Bulow J, Hovind P, Simonsen L. The Copenhagen Sarcopenia Study: lean mass, strength, power, and physical function in a Danish cohort aged 20-93 years. J Cachexia Sarcopenia Muscle. 2019 Dec;10(6):1316-1329. doi: 10.1002/jcsm.12477. Epub 2019 Aug 16.
Other Identifiers
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SarcoCKD2020
Identifier Type: -
Identifier Source: org_study_id
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