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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient | Patients with cirrhosis according to the 2021 EASL criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fitting a blood glucose sensor | Other | automatic, continuous collection by the blood glucose sensor for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria:
Exclusion Criteria:
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Cirrhotic subjects will be recruited from the hepato-gastroenterology departments of the centres taking part in this clinical study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas MOUILLOT | Contact | 0380293750 | +33 | Thomas.mouillot@chu-dijon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Dijon Bourgogne | Recruiting | Dijon | 21000 | France |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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 |
|
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |