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Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis

A legfontosabb adatok

Ki végzi
Centre Hospitalier Universitaire Dijon
Hol
Franciaország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Toboroz
Résztvevők
200 fő, tervezett
Kezdés
2025. szept. 9.
Várható befejezés
2027. okt.
A vizsgálat típusa
Megfigyeléses
A vizsgált kezelések
  • fitting a blood glucose sensor
  • food collection
  • tests and questionnaires
A regiszteradat frissítve
2025. szeptember 16.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

The trial is looking for adults with cirrhosis who have regular check-ups every six months. It studies whether low blood sugar at night is linked to muscle loss.

Életkor
18 years and older
Nem
All sexes
A betegség stádiuma
Cirrhosis according to the 2021 EASL criteria. Regular six-monthly follow-up, including a liver scan by MRI and/or CT to check for liver cancer (HCC).
Korábbi kezelés
People cannot join if they take systemic corticosteroids now or took them in the last 3 months.

A részvétel fő kizáró okai

  • Active cancer, or cancer treated in the last 6 months
  • A sudden worsening of cirrhosis in the last month, such as infection, bleeding in the gut, brain problems from the liver, or acute alcoholic hepatitis
  • Having had an organ transplant
  • Pregnant or breast-feeding women
  • Adults under legal protection or unable to give consent

A regiszter feltételei, szó szerint

Mind a 15 feltétel megnézéseKevesebb

Ki vehet részt

  • 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)

Ki nem vehet részt

  • Treatment with systemic corticosteroids, in progress or within the last 3 months
  • Patient with organ transplant
  • 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
  • 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

Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.

Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.

A vizsgálatról

Mit akar kideríteni a vizsgálat

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%.

A teljes eredeti leírásKevesebb

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.

A vizsgálat csoportja

  • patient

    Patients with cirrhosis according to the 2021 EASL criteria

    Kezelés: fitting a blood glucose sensor, food collection és tests and questionnaires

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 14.
A regiszteradat frissítve
2025. szeptember 16.