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

NCT07586956 | Not Yet Recruiting

• 1 other identifier: Sohag-Med-26-2-11MS
• Study Type: observational
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Sarcopenia; ESRD (End Stage Renal Disease)

Keywords

Sarcopenia; ESRD; dialysis; IGF-1; Serum albumin; IGF-1:albumin ration

Outcome Measures

Primary Outcomes (1)

• correlation between the serum IGF-1/Albumin ratio and the severity of sarcopenia

  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

Study Arms (1)

Cases

Cases: 110 patients who are ESRD on regular dialyis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• \- 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).
• \. Willing and able to provide informed consent.

You may not qualify if:

• \. 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.
• \. Acute inflammatory conditions (e.g., systemic lupus erythematosus flare, vasculitis).
• \. Pregnancy.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Sarcopenia; Renal Insufficiency, Chronic; Kidney Failure, Chronic

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

Study Officials

• Alo T Ali Hassan, Professor

  Sohag University

  STUDY DIRECTOR

• Hany A Mohamed Khalil, Lecturer

  Sohag University

  STUDY DIRECTOR

Central Study Contacts

Marian S Ibrahim

CONTACT

+201018613150; marian_saeed-post@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Resident - Sohag University Hospitals

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share