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CompletedNCT05583890

A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients vs Healthy Matched Individuals.

A Case-control Study Comparing Glycaemic Control in Pancreatic Cancer Patients Versus Age Matched Healthy Individuals Using Continuous Glucose Monitors.

Status
Completed
Phase
Study type
Observational
Enrollment
29 (actual)
Sponsor
Lancaster University · Academic / Other
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DEVICEContinuous glucose monitorsParticipants will wear continuous glucose monitors for a 7 day period.
DEVICEActivity trackerParticipants will wear the activity tracker for a 7 day period.
BEHAVIORALFood DiaryParticipants will complete a food diary of everything they eat for 7 days.
BEHAVIORALQuestionnairesParticipants will complete FACT-Hep, DiPcare-Q and health inequality related questions.

Timeline

Start date
2022-08-25
Primary completion
2024-08-21
Completion
2024-08-28
First posted
2022-10-18
Last updated
2025-06-04

Locations

2 sites across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT05583890. Inclusion in this directory is not an endorsement.