Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis

Sponsor
Centre Hospitalier Universitaire Dijon
Study ID
NCT06948656
Status
Recruiting
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Conditions

  • Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • fitting a blood glucose sensor — OTHER
    automatic, continuous collection by the blood glucose sensor for 14 days
  • food collection — OTHER
    14-day dietary record in a notebook for the 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

Study Details

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.

Key Dates

First listed
Apr 29, 2025
Start date
Sep 9, 2025
Status verified
Sep 2025
Primary completion
Oct 31, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: patient
    Patients with cirrhosis according to the 2021 EASL criteria

Primary Outcome Measure

The number of nocturnal dysglycaemic events by the blood glucose sensor [ Time Frame: For 14 days ]

Central Contacts

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