How low blood sugar at night affects muscle loss in cirrhosis
Official title: Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis
Run by Centre Hospitalier Universitaire Dijon · NCT06948656 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Centre Hospitalier Universitaire Dijon Academic / other |
| Locations | 1 site (Dijon) |
| Status | Recruiting |
| Started | September 9, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | September 16, 2025 |
| Trial ID | NCT06948656 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
CHU Dijon Bourgogne
Dijon, France Recruiting
Study contacts
- Study coordinator: Thomas MOUILLOT
- Email: Thomas.mouillot@chu-dijon.fr
- Phone: 0380293750
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.