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

January 3, 2024 updated by: Dr. Chris Gaffney, Lancaster University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Pancreatic cancer patients aged between 18 and 85 with a performance status of 2 and below. The patients must have jaundice relieved before participating and cannot have diabetes at the point of diagnosis.

Healthy participants must be between 18-85 and age matched to the pancreatic cancer patients. The participants must not have any serious underlying health conditions or take any medications which may alter glycaemic control.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy participants
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.
Device: Continuous glucose monitors
Participants will wear continuous glucose monitors for a 7 day period.
Device: 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.
Behavioral: Questionnaires
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Pancreatic cancer patients undergoing chemotherapy
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations whilst they are undergoing chemotherapy. Participants will also complete questionnaires related to health inequalities and quality of life.
Device: Continuous glucose monitors
Participants will wear continuous glucose monitors for a 7 day period.
Device: 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.
Behavioral: Questionnaires
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.
Pancreatic cancer patients not undergoing chemotherapy
Continuous glucose monitors will be fitted for 7 days, along with activity trackers and a food diary to monitor the impact of these factors on blood glucose concentrations. Participants will also complete questionnaires related to health inequalities and quality of life.
Device: Continuous glucose monitors
Participants will wear continuous glucose monitors for a 7 day period.
Device: 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.
Behavioral: Questionnaires
Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 day period
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.
7 day period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lancaster University

Collaborators

East Lancashire Hospitals NHS Trust

Investigators

  • Principal Investigator: Christopher J Gaffney, Lancaster University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 25, 2022

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

October 11, 2022

First Submitted That Met QC Criteria

October 13, 2022

First Posted (Actual)

October 18, 2022

Study Record Updates

Last Update Posted (Actual)

January 5, 2024

Last Update Submitted That Met QC Criteria

January 3, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NHS REC no: 315235

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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