CirrhosisHYPOCIRNCT06948656
Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis
An observational study of Cirrhosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis
- What is being tested?
- fitting a blood glucose sensor, food collection and tests and questionnaires
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cirrhotic subjects will be recruited from the hepato-gastroenterology departments of the centres taking part in this clinical study.
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Thomas MOUILLOT, 0380293750 ext. +33, Thomas.mouillot@chu-dijon.fr
About this study
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.
Read more
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
- Being tested
- fitting a blood glucose sensor, food collection, tests and questionnaires
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fitting a blood glucose sensorOther
automatic, continuous collection by the blood glucose sensor for 14 days
food collectionOther
14-day dietary record in a notebook for the patient
tests and questionnairesOther
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 group | Role | What they receive |
|---|---|---|
| patient | Patients with cirrhosis according to the 2021 EASL criteria Receives: Other: fitting a blood glucose sensor; Other: food collection; Other: tests and questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: For 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start9 Sep 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948656
- Sponsor's protocol ID
- MOUILLOT AFEF-AOI 2023
- Acronym
- HYPOCIR
- Status last verified
- Sep 2025
- First submitted
- 18 Apr 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of HYPOglycaemia on Sarcopenia in CIRrhosis
- ClinicalTrials.gov ID
- NCT06948656
- Acronym / sponsor ID
- HYPOCIR / MOUILLOT AFEF-AOI 2023
- Conditions
- Cirrhosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 9 Sep 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: fitting a blood glucose sensor, Other: food collection, Other: tests and questionnairesPatients with cirrhosis according to the 2021 EASL criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhotic subjects will be recruited from the hepato-gastroenterology departments of the centres taking part in this clinical study.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fitting a blood glucose sensorautomatic, continuous collection by the blood glucose sensor for 14 days | Other | patient |
| food collection14-day dietary record in a notebook for the patient | Other | patient |
| tests and questionnairesmeasurement of muscle strength using a hand-held dynamometer, animal enumeration test, self-questionnaire on the frequency of consumption of the main food groups | Other | patient |
Primary outcome
The number of nocturnal dysglycaemic events by the blood glucose sensor
Time frame: For 14 days
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.
Duration of nocturnal dysglycaemic events by the blood glucose sensor
Time frame: For 14 days
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.
The severity of nocturnal dysglycaemic events by the blood glucose sensor
Time frame: For 14 days
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas MOUILLOT (0380293750 ext. +33, Thomas.mouillot@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of nocturnal dysglycaemic events by the blood glucose sensor (time frame: For 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.