A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.
NCT ID: NCT05583890
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
29 participants
OBSERVATIONAL
2022-08-25
2024-08-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Healthy participants
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.
Continuous glucose monitors
Participants will wear continuous glucose monitors for a 7 day period.
Activity tracker
Participants will wear the activity tracker for a 7 day period.
Food Diary
Participants will complete a food diary of everything they eat for 7 days.
Questionnaires
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Pancreatic cancer patients undergoing chemotherapy
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations whilst they are undergoing chemotherapy. Participants will also complete questionnaires related to health inequalities and quality of life.
Continuous glucose monitors
Participants will wear continuous glucose monitors for a 7 day period.
Activity tracker
Participants will wear the activity tracker for a 7 day period.
Food Diary
Participants will complete a food diary of everything they eat for 7 days.
Questionnaires
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Pancreatic cancer patients not undergoing chemotherapy
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.
Continuous glucose monitors
Participants will wear continuous glucose monitors for a 7 day period.
Activity tracker
Participants will wear the activity tracker for a 7 day period.
Food Diary
Participants will complete a food diary of everything they eat for 7 days.
Questionnaires
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Interventions
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Continuous glucose monitors
Participants will wear continuous glucose monitors for a 7 day period.
Activity tracker
Participants will wear the activity tracker for a 7 day period.
Food Diary
Participants will complete a food diary of everything they eat for 7 days.
Questionnaires
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
Yes
Sponsors
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East Lancashire Hospitals NHS Trust
OTHER
Lancaster University
OTHER
Responsible Party
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Dr. Chris Gaffney
Dr
Principal Investigators
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Christopher J Gaffney
Role: PRINCIPAL_INVESTIGATOR
Lancaster University
Locations
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Lancaster University
Lancaster, Lancashire, United Kingdom
East Lancashire Hospitals Trust
Blackburn, , United Kingdom
Countries
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Other Identifiers
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NHS REC no: 315235
Identifier Type: -
Identifier Source: org_study_id
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