Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis

NCT ID: NCT06948656

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-09
• Study Completion Date: 2027-10-31

Brief Summary

Fasting blood glucose is maintained by hepatic production of glucose from glycogenolysis or gluconeogenesis. In cirrhosis, glycogen storage capacity is reduced, with a consequent increase in gluconeogenesis to maintain blood glucose levels. Hypoglycaemia is particularly common during periods of prolonged nocturnal fasting. Cirrhosis can therefore be considered an 'accelerated fasting' disease. In a recent study, Honda et al. described 22% nocturnal hypoglycaemia in 105 patients analysed continuously. A previous study showed that the percentage of hypoglycaemia over the total duration of continuous blood glucose recording averaged 4%.

This gluconeogenesis could lead to a significant increase in muscle and fat catabolism, which would aggravate sarcopenia and lead to undernutrition. Undernutrition and sarcopenia are serious and severe in cirrhotic patients. Sarcopenia, present in around 45% to 67% of cirrhotic patients, is thought to lead to a significant increase in the morbidity and mortality of cirrhotic patients. Glycaemic disorders appear to play a major role in this sarcopenia. Shortening the duration of fasting, and therefore of proteolysis and lipolysis, by taking a snack in the evening, could improve nitrogen balance and glucose tolerance.

However, no study has clearly established the relationship between variations in continuous monitoring of interstitial glucose, particularly periods of nocturnal hypoglycaemia, and sarcopenia. New technologies in diabetology make it possible to obtain continuous monitoring of interstitial glucose. In addition, the use of muscle surface area at the level of the 3rd lumbar vertebra or the diameter of the psoas, obtained by scanner or MRI, combined with the use of a hand-held dynamometer to quantify muscle strength, make it easier to diagnose and assess the severity of sarcopenia and malnutrition.

The hypothesis of this work is based on the probable correlation between the time spent in hypoglycaemia (glycaemia < 0.7 g/l) and the presence of sarcopenia responsible for undernutrition in cirrhotic patients.

If positive, the results of this descriptive pilot study could provide fundamental data for anticipating and better managing sarcopenia and glycaemic disorders. The results will enable a multi-centre randomised controlled intervention trial to be set up to optimise nutritional management of patients and thus effectively combat undernutrition in cirrhotic patients.

Conditions

Cirrhosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patient

Patients with cirrhosis according to the 2021 EASL criteria

fitting a blood glucose sensor

Intervention Type: OTHER

automatic, continuous collection by the blood glucose sensor for 14 days

food collection

Intervention Type: OTHER

14-day dietary record in a notebook for the patient

tests and questionnaires

Intervention Type: OTHER

measurement of muscle strength using a hand-held dynamometer, animal enumeration test, self-questionnaire on the frequency of consumption of the main food groups

Interventions

fitting a blood glucose sensor

automatic, continuous collection by the blood glucose sensor for 14 days

Intervention Type: OTHER

food collection

14-day dietary record in a notebook for the patient

Intervention Type: OTHER

tests and questionnaires

measurement of muscle strength using a hand-held dynamometer, animal enumeration test, self-questionnaire on the frequency of consumption of the main food groups

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU Dijon Bourgogne

Dijon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Thomas MOUILLOT

Role: CONTACT

Thomas.mouillot@chu-dijon.fr

0380293750 ext. +33

Facility Contacts

Thomas MOUILLOT

Role: primary

Thomas.mouillot@chu-dijon.fr

0380293750 ext. +33

Other Identifiers

MOUILLOT AFEF-AOI 2023

Identifier Type: -

Identifier Source: org_study_id