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NCT Number: NCT05583890

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lancaster University, Lancaster, Lancashire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitors

Device

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

Activity Tracker

Device

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

Food Diary

Behavioral

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

Questionnaires

Behavioral

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

Primary outcomes

  1. Glycaemic control

    Time frame: 7 day period

    Glycaemic 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.

  2. Health inequalities

    Time frame: 7 day period

    Health 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.

Sponsors and collaborators

Lead sponsor

Lancaster University

Other

Collaborators

  • East Lancashire Hospitals NHS Trust

Registry information

Official study title

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

Acronym: PanCanCGM

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 18, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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