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

Pancreatic Cancer Clinical Trial

— PanCanCGM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583890
• Other study ID #: NHS REC no: 315235
• Status: Recruiting
• Start date: August 25, 2022
• Est. completion date: August 30, 2024

Study information

• Verified date: January 2024
• Source: Lancaster University
• Contact: Elizabeth Wrench
• Phone: +44 (0) 1524 593 602
• Email: l.wrench[@]lancaster.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: August 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United Kingdom	East Lancashire Hospitals Trust	Blackburn
United Kingdom	Lancaster University	Lancaster	Lancashire

Sponsors (2)

Lead Sponsor	Collaborator
Lancaster University	East Lancashire Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycaemic control	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.	7 day period
Primary	Health inequalities	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.	7 day period