Sarcopenia, Fall and Osteoporosis in Chronic Kidney Disease

NCT04515342 | Recruiting

• 1 other identifier: SarcoCKD2020
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 2

Brief Summary

This study is a cross-sectional study that wishes to investigate whether there is an increased incidence of sarcopenia in patients with chronic kidney disease compared to the Danish background population. A possible association between sarcopenia and fall, as well as the incidence of osteoporosis in patients with chronic kidney disease will also be described.

Conditions

Sarcopenia; Chronic Kidney Diseases; Osteoporosis

Keywords

Fall; Chronic kidney disease-mineral and bone disorder (CKD-MBD)

Outcome Measures

Primary Outcomes (1)

• Difference in appendicular lean body mass

  Difference in appendicular lean body mass between patients with chronic kidney disease and a healthy control group examined in a previous study

  Day 0 (day of study procedure)

Secondary Outcomes (8)

• Difference in the incidence of sarcopenia

  Day 0 (day of study procedure)

• Difference in appendicular muscle mass

  Day 0 (day of study procedure)

• Difference in handgrip strength

  Day 0 (day of study procedure)

• Difference in gait speed

  Day 0 (day of study procedure)

• Difference in sit-to-stand test

  Day 0 (day of study procedure)

Study Arms (1)

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.

Diagnostic Test: DXA; Other: Muscle strength and function assessment; Other: Blood samples

Interventions

DXA DIAGNOSTIC_TEST

Each participant will undergo one DXA scan

Participants

Muscle strength and function assessment OTHER

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).

Participants

Blood samples OTHER

Each patient will undergo a physical examination and also deliver blood samples.

Participants

Eligibility Criteria

• Age: 20 Years - 120 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients will be recruited from the Department of Nephrology at both Herlev Hospital and Odense University Hospital during their regular visits to these outpatient clinics. All subjects connected to the participating centers are screened to see if they are eligible for the study. Participants with a minimum age of 20 with eGFR ≤30 ml/min are asked if they wish to be examined further to see if they meet all the inclusion criteria and none of the exclusion criteria. Only participants meeting all the inclusion criteria and none of the exclusion criteria will be considered eligible for the trial.

You may qualify if:

• Age ≥20 years
• 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)

You may not qualify if:

• Kidney transplanted
• 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

Sponsors & Collaborators

• Herlev Hospital: lead
• Odense University Hospital: collaborator

Study Sites (2)

Herlev and Gentofte Hospital, Herlev Hospital

Herlev, 2730, Denmark

RECRUITING

Odense University Hospital

Odense, 5000, Denmark

NOT YET RECRUITING

Related Publications (1)

• 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.

  PMID: 31419087 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples (serum, plasma)

MeSH Terms

Conditions

Sarcopenia; Renal Insufficiency, Chronic; Osteoporosis; Bone Diseases; Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

Muscle Strength; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Bone Diseases, Metabolic; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Rickets; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Ditte Hansen, MD, PhD

  Department of Nephrology, Herlev and Gentofte Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabina C Hauge, MD

CONTACT

+45 28965887; sabina.chaudhary.hauge@regionh.dk

Ditte Hansen, MD, PhD

CONTACT

+45 38682056; ditte.hansen.04@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, MD, PhD

Study Record Dates

• First Submitted: August 13, 2020
• First Posted: August 17, 2020
• Study Start: March 10, 2021
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)