How low blood sugar at night affects muscle loss in cirrhosis

Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis

This will see if episodes of low blood sugar, especially overnight, speed up muscle loss in adults with cirrhosis by using a wearable glucose sensor, food records, and health questionnaires.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire Dijon (Academic / other)
• Locations: 1 site (Dijon)
• Trial ID: NCT06948656 on ClinicalTrials.gov

What this trial studies

Cirrhosis reduces liver glycogen and increases gluconeogenesis, which can lead to frequent nocturnal hypoglycaemia and may drive muscle and fat breakdown that worsens sarcopenia. This observational study uses continuous glucose monitoring, dietary collection, clinical tests, and questionnaires to measure the burden of hypoglycaemia and nutritional status in people with cirrhosis. Eligible adults are those followed regularly under EASL-recommended monitoring, with exclusions for recent decompensation, active cancer, recent systemic steroids, or organ transplant. The aim is to correlate hypoglycaemia exposure with objective markers of sarcopenia and undernutrition to inform possible preventive strategies.

Who should consider this trial

Good fit: Adults (≥18) with cirrhosis according to 2021 EASL criteria who are in regular six‑monthly follow-up and can give oral consent, without recent decompensation, active cancer, recent systemic corticosteroid use, or organ transplant.

Not a fit: Patients with active cancer, recent cirrhosis decompensation, ongoing or recent systemic corticosteroid treatment, or organ transplant are excluded and unlikely to receive benefit from this protocol.

Why it matters

Potential benefit: If successful, findings could help clinicians detect and prevent muscle wasting in cirrhosis by targeting nighttime hypoglycaemia with nutritional or metabolic interventions.

How similar studies have performed: Previous continuous glucose monitoring studies in cirrhosis (for example Honda et al.) have shown frequent nocturnal hypoglycaemia, but directly linking hypoglycaemia burden to sarcopenia is a relatively novel approach.

Eligibility criteria

Inclusion criteria:

* Age ≥18 years
* Person with oral consent
* Patient with cirrhosis according to the 2021 EASL criteria (1)
* Patient receiving regular six-monthly and systematic monitoring of cirrhosis, according to the European recommendations of the EASL (2), or French recommendations of the TNCD (3) and HAS (4), including a clinical examination, a biological work-up (to calculate the CHILD-PUGH score and monitor alpha-feto-protein), AND requiring imaging to screen for HCC of hepatocellular carcinoma using cross-sectional imaging (by MRI and/or hepatic CT scan).

Exclusion Criteria:

* Patients with active cancer or treated within the last 6 months
* Patient with an acute episode of cirrhosis decompensation (ongoing antibiotic treatment for an active infection, gastrointestinal bleeding, hepatic encephalopathy, acute alcoholic hepatitis) less than one month old.
* Treatment with systemic corticosteroids, in progress or within the last 3 months
* Patient with organ transplant
* Person not affiliated to or not benefiting from a social security scheme
* Person under legal protection (curatorship, guardianship)
* Person subject to a legal protection measure
* Pregnant or breast-feeding women
* An adult who is incapable or unable to give consent
* Minors
* Patients already included in an interventional study who may interfere with the evaluation of this study.

Where this trial is running

Dijon

• CHU Dijon Bourgogne — Dijon, France (Recruiting)

Study contacts

• Study coordinator: Thomas MOUILLOT

Conditions Cirrhosis