Actively Recruiting

Age: 18Years +
All Genders
NCT06948656

Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis

Led by Centre Hospitalier Universitaire Dijon · Updated on 2025-09-16

200

Participants Needed

1

Research Sites

107 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Able to provide oral consent
  • Diagnosed with cirrhosis according to 2021 EASL criteria
  • Under regular six-monthly monitoring for cirrhosis, including clinical exams, biological work-up (for CHILD-PUGH score and alpha-feto-protein), and imaging (MRI and/or CT scan) to screen for hepatocellular carcinoma
Not Eligible

You will not qualify if you...

  • Active cancer or cancer treated within the last 6 months
  • Acute episode of cirrhosis decompensation less than one month old
  • Current or recent (within 3 months) systemic corticosteroid treatment
  • Organ transplant recipient
  • Not covered by a social security scheme
  • Under legal protection (curatorship, guardianship) or subject to legal protection measures
  • Pregnant or breastfeeding women
  • Unable or incapable of giving consent
  • Minors
  • Currently enrolled in an interventional study that may interfere with this study

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Trial Site Locations

Total: 1 location

1

CHU Dijon Bourgogne

Dijon, France, 21000

Actively Recruiting

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Research Team

T

Thomas MOUILLOT

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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