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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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.
Sarcopenia is a condition diagnosed from different clinical findings such as low muscle mass, low muscle strength and possibly also poor physical performance. In the general population, the risk of fall and bone fracture increases, when sarcopenia is also present.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DXA | Diagnostic Test | Each participant will undergo one DXA scan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the incidence of sarcopenia | Difference in the incidence of sarcopenia between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) |
| Difference in appendicular muscle mass |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sabina C Hauge, MD | Contact | +45 28965887 | sabina.chaudhary.hauge@regionh.dk | |
| Ditte Hansen, MD, PhD | Contact | +45 38682056 | ditte.hansen.04@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Ditte Hansen, MD, PhD | Department of Nephrology, Herlev and Gentofte Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Herlev and Gentofte Hospital, Herlev Hospital | Recruiting | Herlev | 2730 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31419087 | Background | 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. |
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For now no Individual Participant Data (IPD) are planned to be shared with other researchers.
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D051436 | Renal Insufficiency, Chronic |
| D010024 | Osteoporosis |
| D001847 | Bone Diseases |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D053580 | Muscle Strength |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D009142 | Musculoskeletal Physiological Phenomena |
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Blood samples (serum, plasma)
| 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). |
|
| Blood samples | Other | Each patient will undergo a physical examination and also deliver blood samples. |
|
Difference in appendicular muscle mass between patients with chronic kidney disease and a healthy control group examined in a previous study |
| Day 0 (day of study procedure) |
| Difference in handgrip strength | Difference in handgrip strength between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) |
| Difference in gait speed | Difference in gait speed between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) |
| Difference in sit-to-stand test | Difference in sit-to-stand test between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) |
| Difference in the incidence of osteoporosis | Difference in the incidence of osteoporoses between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) |
| Difference in the tendency to fall | Difference in the tendency to fall between patients with chronic kidney disease and a healthy control group examined in a previous study | Day 0 (day of study procedure) |
| The correlation between total lean and appendicular lean body mass, handgrip strength, gait speed, sit-to-stand test, tendency to fall and osteoporosis | The correlation between total lean and appendicular lean body mass, handgrip strength, gait speed, sit-to-stand test, tendency to fall and osteoporosis (T-score <-2.5 in hip and/or lumbal spine) | Day 0 (day of study procedure) |
| Odense University Hospital | Not yet recruiting | Odense | 5000 | Denmark |
|
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D001851 | Bone Diseases, Metabolic |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012279 | Rickets |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |