Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis

NCT06948656 | Recruiting

• 1 other identifier: MOUILLOT AFEF-AOI 2023
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• The number of nocturnal dysglycaemic events by the blood glucose sensor

  Defined by an episode of hypoglycaemia (blood glucose \< 0.7 g/L), severe hypoglycaemia (blood glucose \< 0.55 g/L) or hyperglycaemia (blood glucose \> 1.8 g/L) lasting at least 15 consecutive minutes) of continuous recording of interstitial blood glucose (with Freestyle libre®). The nocturnal period is defined as the period between 11pm and 7am.

  For 14 days

• Duration of nocturnal dysglycaemic events by the blood glucose sensor

  Defined by an episode of hypoglycaemia (blood glucose \< 0.7 g/L), severe hypoglycaemia (blood glucose \< 0.55 g/L) or hyperglycaemia (blood glucose \> 1.8 g/L) lasting at least 15 consecutive minutes) of continuous recording of interstitial blood glucose (with Freestyle libre®). The nocturnal period is defined as the period between 11pm and 7am.

  For 14 days

• The severity of nocturnal dysglycaemic events by the blood glucose sensor

  Defined by an episode of hypoglycaemia (blood glucose \< 0.7 g/L), severe hypoglycaemia (blood glucose \< 0.55 g/L) or hyperglycaemia (blood glucose \> 1.8 g/L) lasting at least 15 consecutive minutes) of continuous recording of interstitial blood glucose (with Freestyle libre®). The nocturnal period is defined as the period between 11pm and 7am.

  For 14 days

Study Arms (1)

patient

Patients with cirrhosis according to the 2021 EASL criteria

Other: fitting a blood glucose sensor; Other: food collection; Other: tests and questionnaires

Interventions

fitting a blood glucose sensor OTHER

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

patient

food collection OTHER

14-day dietary record in a notebook for the patient

patient

tests and questionnaires 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

patient

Eligibility Criteria

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

Study Population

Cirrhotic subjects will be recruited from the hepato-gastroenterology departments of the centres taking part in this clinical study.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21000, France

RECRUITING

MeSH Terms

Conditions

Fibrosis

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Thomas MOUILLOT

CONTACT

0380293750; Thomas.mouillot@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 29, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)