None listed
Conditions
Brief summary
Chronic liver disease including cirrhosis may be associated with an HbA1c test (a diabetes blood test that looks indirectly at long term glucose values) that underestimates true (venous or interstitial) glucose. In patients on anti-retroviral agents, this finding is likely to be due to haemolysis and associated changes in red cell turnover. In patients with cirrhosis but not on anti-retrovirals, the mechanism for this ‘artefactual’ low HbA1c is poorly understood. Currently, has been suggested that the 30% of patients with cirrhosis and diabetes (much of which is undiagnosed), be diagnosed using an oral glucose tolerance test, rather than an HbA1c blood test. This feasibility study explores whether or not interstitial glucose can be used as an alternative method of diagnosing diabetes and impaired glucose tolerance, in this population of patients with cirrhosis. The study will also explore the relationship with HbA1c. A better understanding of possible discordance between HbA1c and venous glucose value in patients with chronic liver disease, will aid the diagnosis and management of pre-diabetes and diabetes in this population.
Interventions
Summary of measurements of glycaemia to be undertaken during this study; i) Laboratory HbA1c (glycated haemoglobin), ii) 75gm OGTT (oral glucose tolerance test), iii) Libre Pro interstitial glucose monitoring over 14 days, with results obtained using the Libre Pro system.
1. What these tests mean from a participant perspective:
i) HbA1c. Single venous blood sample as part of the baseline blood test at the start of the half day research clinic visit.
ii) 75gm OGTT. This will be undertaken duri
Summary of measurements of glycaemia to be undertaken during this study; i) Laboratory HbA1c (glycated haemoglobin), ii) 75gm OGTT (oral glucose tolerance test), iii) Libre Pro interstitial glucose monitoring over 14 days, with results obtained using the Libre Pro system. 1. What these tests mean from a participant perspective: i) HbA1c. Single venous blood sample as part of the baseline blood test at the start of the half day research clinic visit. ii) 75gm OGTT. This will be undertaken during the half day research clinic visit. Baseline venous glucose blood test, followed by 75gm glucose drink that may take 5 minutes or so to consume, followed by a second and third venous plasma glucose blood test at 1 hour and 2 hours. iii) Libre Pro interstitial glucose monitoring. Once the participant has finishing drinking the 75gm glucose drink, the sensor will be inserted into the subcutaneous tissue of the upper arm (usually non-dominant arm). This procedure takes a few minutes. The sensor will remain in situ for 14 days, then posted back by the participant to the research clinic. 2. Total duration of the intervention is around 14 days. It concludes with a phone follow up with the participant, to discuss their perceptions of interstitial glucose monitoring versus OGTT as a diagnostic test. In addition, this phone follow up provides an opportunity to review participant's laboratory study results. 3. Administration of the intervention. This will be led by GCP trained research nurses and also a medical student summer student who will be working under the nurses' supervision. The participant will attend for a half day visit at the Endocrinology Specialist Test Centre, Christchurch Hospital campus. The participant will remove the interstitial glucose sensor at 14 days and return the sensor to the investigators, by post. Abnormal results emerging from the study will be followed up by one of the research doctors taking part in this study. 4. Fidelity. Each participant will have a research file for noting details such as dates and times of their intervention, time and content of phone follow up. Any deviations from the protocol will be noted in their file. The 75gm OGTT will be administered as per local special test centre protocol. Blood samples will be analysed at an accredited clinical laboratory (Canterbury Health Laboratories, Christchurch, New Zealand).
Sponsors
Endocrinology services, Canterbury District Health Board
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Severe liver disease defined as: Biopsy Stage 4 cirrhosis or liver stiffness measured as greater or equal to 12.5kpa on Fibroscan.
Exclusion criteria
A pre-existing diagnosis of diabetes. On medications or treatments or underlying disease that is likely to shorten red cell survival or interfere with interpretation of laboratory HbA1c. .
Outcome results
None listed