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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05583890
Acronym
PanCanCGM
Enrollment
29
Registered
2022-10-18
Start date
2022-08-25
Completion date
2024-08-28
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Glycaemic control, Continuous glucose monitoring

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.

Interventions

Participants will wear continuous glucose monitors for a 7 day period.

Participants will wear the activity tracker for a 7 day period.

BEHAVIORALFood Diary

Participants will complete a food diary of everything they eat for 7 days.

BEHAVIORALQuestionnaires

Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.

Sponsors

East Lancashire Hospitals NHS Trust
CollaboratorOTHER
Lancaster University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Glycaemic control7 day periodGlycaemic control will be assessed by continuous glucose monitors for a 7-day period with activity trackers and food diaries used to further assess this control. The continuous glucose monitors takes readings every 5 minutes these readings will be averaged and area under the curve will be calculated.
Health inequalities7 day periodHealth inequalities, including household income, access to green space, main occupation, smoking habits, support system, ethnicity and religion assessed by specific questions and DipCare-Q questionnaires completed. Analyses determining the impact of inequalities on glyceamic control will be completed.

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026