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

Last updated: January 3, 2024
Sponsor: Lancaster University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Digestive System Neoplasms

Pancreatitis

Treatment

Food Diary

Continuous glucose monitors

Questionnaires

Clinical Study ID

NCT05583890
NHS REC no: 315235
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 atrisk 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/glucagonconcentrations, regular paracetamol intake during the study period, corticosteroids,thyroid hormones, or any anti-diabetes medication including insulin and oralhypoglycaemics.
  • Pregnant

Study Design

Total Participants: 45
Treatment Group(s): 4
Primary Treatment: Food Diary
Phase:
Study Start date:
August 25, 2022
Estimated Completion Date:
August 30, 2024

Study 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.

Connect with a study center

  • Lancaster University

    Lancaster, Lancashire LA1 4YW
    United Kingdom

    Active - Recruiting

  • East Lancashire Hospitals Trust

    Blackburn, BB2 3HH
    United Kingdom

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.