Clinical trial NCT05583890: A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.
Official title: A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients Versus Age Matched Healthy Individuals Using Continuous Glucose Monitors.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: Glycaemic control
Continuous glucose monitoring
Lead sponsor: Lancaster University
Sponsor class: OTHER
Collaborators: name: East Lancashire Hospitals NHS Trust
First posted: 2022-10-18
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pancreatic cancer patients aged between 18 and 85 with a performance status of 2 and below. The patients must have jaundice relieved before participating and cannot have diabetes at the point of diagnosis.

Healthy participants must be between 18-85 and age matched to the pancreatic cancer patients. The participants must not have any serious underlying health conditions or take any medications which may alter glycaemic control.

Brief summary: The aim of this study is to continuously monitor blood glucose concentrations for a 7-day period in pancreatic cancer patients whilst undergoing their typical daily routines and to compare this to age matched healthy individuals. The investigators plan to carry out the study on a small subset of patients, up to 30 with pancreatic cancer (15 not undergoing chemotherapy and 15 undergoing chemotherapy) and 15 healthy individuals.

Detailed description: The pancreas has two key functions related to digestion and metabolism. The first function of the pancreas is to produce exocrine enzymes which are released into the small intestine to help with the digestion of food. The second function is to produce endocrine hormones, such as insulin and glucagon, which help regulate glycaemic control. Impaired glucose metabolism and pancreatic cancer is temporally and pathogenically linked, with pancreatic tumours altering the secretion of key glucose regulatory hormones. Improved glucose regulation and lower glucose concentrations 3 months post-diagnosis of pancreatic ductal adenocarcinoma, a type of pancreatic cancer, has shown to increase overall survival.

The aim of this study is to continuously monitor blood glucose concentrations for a 7-day period in pancreatic cancer patients whilst undergoing their typical daily routines and to compare this to age matched healthy individuals. The comparison between healthy individuals and pancreatic cancer patients will investigate the severity of the difference between healthy glycaemic control and glycaemic control in those with pancreatic cancer. The comparison between pancreatic cancer patients undergoing chemotherapy and those not undergoing chemotherapy will help investigate the impact of chemotherapy on glycaemic control. This will help provide evidence as to what impact pancreatic cancer has on glycaemic control, whether continuous glucose monitors might be useful to regulate symptoms in patients, as a baseline to tailor an exercise intervention to regulate blood glucose concentrations and to investigate whether health inequalities impact glycaemic control.

The investigators plan to carry out the study on a small subset of patients, 30 with pancreatic cancer (15 undergoing chemotherapy and 15 not undergoing chemotherapy) and 15 healthy individuals.

Eligibility criteria: Pancreatic cancer patients

Inclusion Criteria:

* Aged 18-85
* Sex: male/female
* Radiological/tissue cancer diagnosis
* World Health Organisation performance status of 2 or below
* Patients with jaundice must have jaundice relieved before participating

Exclusion Criteria:

* Pregnancy
* Planned surgery within the 7 days of wearing the monitor
* Emergency surgery
* Part of any other trial with similar interventions
* Any musculoskeletal, cardiovascular, or neurological disorder that could put them at risk during the protocol.
* World Health Organisation performance status of above 2.
* Have diabetes at the point of diagnosis.

Healthy control group

Inclusion:

* Aged 18-85
* No serious underlying health conditions
* Age matched to pancreatic cancer patients

Exclusion:

* Take any medications which may alter blood glucose concentrations or insulin/glucagon concentrations, regular paracetamol intake during the study period, corticosteroids, thyroid hormones, or any anti-diabetes medication including insulin and oral hypoglycaemics.
* Pregnant

Primary outcomes:
measure: Glycaemic control
timeFrame: 7 day period
measure: Health inequalities
timeFrame: 7 day period
Secondary outcomes:
Other outcomes:
Locations:
city: Lancaster
country: United Kingdom
facility: Lancaster University
state: Lancashire
city: Blackburn
country: United Kingdom
facility: East Lancashire Hospitals Trust
Study officials:
affiliation: Lancaster University
name: Christopher J Gaffney
role: PRINCIPAL_INVESTIGATOR
References: