Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Serum Insulin-like Growth Factor-1 to Albumin Ratio as a Biomarker for Sarcopenia Severity in End-Stage Renal Disease Patients on Hemodialysis

7 mei 2026 bijgewerkt door: Marian Saeed Ibrahim, Sohag University

Sarcopenia is a prevalent and serious complication among patients with End-Stage Renal Disease (ESRD) receiving maintenance dialysis, characterized by progressive loss of skeletal muscle mass, strength, and physical function. It is strongly associated with adverse clinical outcomes, including increased mortality, hospitalization, frailty, and reduced quality of life. The development of sarcopenia in ESRD is multifactorial, involving chronic inflammation, metabolic disturbances, hormonal dysfunction, anorexia, and the catabolic effects of dialysis. Although the 2019 EWGSOP2 guidelines recommend assessment of muscle strength, quantity, and physical performance for diagnosis, routine clinical implementation remains limited due to the need for specialized equipment, time constraints, and variability related to fluid status in dialysis patients. Consequently, there is a growing need for accessible and reliable biochemical markers for early identification of patients at risk.

Insulin-like Growth Factor-1 (IGF-1), an essential anabolic mediator of muscle protein synthesis, is often reduced and functionally impaired in ESRD, contributing to anabolic resistance and muscle wasting. Serum albumin, a conventional indicator of nutritional and inflammatory status, reflects the catabolic and inflammatory processes associated with sarcopenia but lacks specificity when used independently. The IGF-1/Albumin ratio may provide a more integrated representation of the balance between anabolic and catabolic pathways underlying uremic sarcopenia. Therefore, this study aims to evaluate the association between the serum IGF-1/Albumin ratio and the presence and severity of sarcopenia, as defined by EWGSOP2 criteria, in stable outpatient dialysis patients.

Studie Overzicht

Toestand

Nog niet aan het werven

Gedetailleerde beschrijving

Sarcopenia, defined as a progressive and generalized loss of skeletal muscle mass, strength, and function, represents a formidable comorbidity in patients with End-Stage Renal Disease (ESRD) undergoing maintenance dialysis (Cruz-Jentoft et al., 2019). Its prevalence in this population is alarmingly high, exceeding 50% in some cohorts, and it is independently associated with increased mortality, hospitalization rates, frailty, and diminished quality of life (Kim et al., 2021; Souza et al., 2017). The pathophysiology of sarcopenia in ESRD is multifactorial, driven by a synergistic interplay of chronic inflammation, metabolic acidosis, anorexia, hormonal derangements (including growth hormone resistance), and the catabolic effects of dialysis itself (Lecker et al., 2006).

The diagnosis of sarcopenia, as per the 2019 European Working Group on Sarcopenia in Older People (EWGSOP2) consensus, requires assessment of muscle strength, muscle quantity/quality, and physical performance (Cruz-Jentoft et al., 2019). In clinical nephrology practice, widespread implementation of these criteria is hindered by the need for specialized equipment (e.g., bioimpedance analysis [BIA], dynamometers), time constraints in dialysis units, and variability in test performance due to fluid shifts. Consequently, there is a critical unmet need for a reliable, easily obtainable serum biomarker that can serve as a surrogate or screening tool for identifying and stratifying patients at risk of severe sarcopenia.

Insulin-like Growth Factor-1 (IGF-1) is a pivotal anabolic hormone mediating the effects of growth hormone on muscle protein synthesis. In ESRD, hepatic production of IGF-1 is reduced, and its bioactivity is impaired due to the accumulation of inhibitory binding proteins and uremic toxicity, contributing to the anabolic resistance characteristic of uremic sarcopenia (Huang et al., 2002). Serum albumin is the classical biomarker of nutritional status and a negative acute-phase reactant; low levels reflect both malnutrition and chronic inflammation, two core drivers of muscle wasting (Carrero et al., 2021). However, albumin alone has limited specificity for sarcopenia.

We hypothesize that the IGF-1/Albumin ratio integrates two key pathophysiological axes of uremic sarcopenia: the anabolic deficit (low IGF-1) and the catabolic/inflammatory state (low albumin). This composite ratio may therefore provide a more comprehensive and robust biochemical reflection of the net balance between muscle synthesis and breakdown than either marker alone. While IGF-1 and albumin have been studied independently in CKD, the diagnostic and prognostic utility of their ratio specifically for sarcopenia severity in dialysis patients remains unexplored. This cross-sectional study aims to investigate the association between the serum IGF-1/Albumin ratio and the presence and severity of sarcopenia, as defined by EWGSOP2 criteria, in a stable outpatient dialysis population.

Studietype

Observationeel

Inschrijving (Geschat)

110

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

ESRD on regular dialysis patient at the outpatient dialysis unit of Sohag university hospital

Beschrijving

Inclusion Criteria:

- 1. Adult patients (age ≥ 18 years). 2. Diagnosis of ESRD on maintenance hemodialysis for > 3 months. 3. Clinically stable (no hospitalization or active infection in the past 4 weeks).

4. Willing and able to provide informed consent.

Exclusion Criteria:

  • 1. Active malignancy or recent chemotherapy/radiotherapy. 2. Decompensated liver cirrhosis (Child-Pugh B or C). 3. Major limb amputation or severe neuromuscular disease precluding functional assessment.

    4. Acute inflammatory conditions (e.g., systemic lupus erythematosus flare, vasculitis).

    5. Pregnancy.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Cases
Cases: 110 patients who are ESRD on regular dialyis

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
correlation between the serum IGF-1/Albumin ratio and the severity of sarcopenia
Tijdsspanne: 6 months
To determine the correlation between the serum IGF-1/Albumin ratio and the severity of sarcopenia (categorized as "no sarcopenia," "probable/sarcopenia," and "severe sarcopenia") in prevalent adult patients on maintenance hemodialysis.
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Studie directeur: Alo T Ali Hassan, Professor, Sohag University
  • Studie directeur: Hany A Mohamed Khalil, Lecturer, Sohag University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 juni 2026

Primaire voltooiing (Geschat)

1 september 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

7 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

7 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren