AzTrials
AzTrials

SarcopeniaNCT07586956

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

An observational study of Sarcopenia and ESRD (End Stage Renal Disease), run by Sohag University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcopenia, ESRD (End Stage Renal Disease)
How many people
110 participants
Where
No sites listed yet
Study dates
1 Jun 2026to 1 Dec 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

About this study

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.

Read the detailed description

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.

Keywords
Sarcopenia, ESRD, dialysis, IGF-1, Serum albumin, IGF-1:albumin ration
Medical subject headings
Sarcopenia, Renal Insufficiency, Chronic, Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07586956
Study groupRoleWhat they receive
CasesCases: 110 patients who are ESRD on regular dialyis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
110 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07586956
Sponsor's protocol ID
Sohag-Med-26-2-11MS
Status last verified
May 2026
First submitted
7 May 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and ESRD (End Stage Renal Disease), run by Sohag University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marian S Ibrahim (+201018613150, marian_saeed-post@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

correlation between the serum IGF-1/Albumin ratio and the severity of sarcopenia (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in