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

Study Overview
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Brief Summary
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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, 30 with pancreatic cancer (15 undergoing chemotherapy and 15 not undergoing chemotherapy) and 15 healthy individuals.

Detailed Description
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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.

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

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Device: Continuous glucose monitors
* Device: Activity tracker
* Behavioral: Food Diary
* Behavioral: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy participants<br>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<br>* Participants will wear continuous glucose monitors for a 7 day period.<br>Device: Activity tracker<br>* Participants will wear the activity tracker for a 7 day period.<br>Behavioral: Food Diary<br>* Participants will complete a food diary of everything they eat for 7 days.<br>Behavioral: Questionnaires<br>* Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.<br>|
| Pancreatic cancer patients undergoing chemotherapy<br>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<br>* Participants will wear continuous glucose monitors for a 7 day period.<br>Device: Activity tracker<br>* Participants will wear the activity tracker for a 7 day period.<br>Behavioral: Food Diary<br>* Participants will complete a food diary of everything they eat for 7 days.<br>Behavioral: Questionnaires<br>* Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.<br>|
| Pancreatic cancer patients not undergoing chemotherapy<br>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<br>* Participants will wear continuous glucose monitors for a 7 day period.<br>Device: Activity tracker<br>* Participants will wear the activity tracker for a 7 day period.<br>Behavioral: Food Diary<br>* Participants will complete a food diary of everything they eat for 7 days.<br>Behavioral: Questionnaires<br>* Participants will complete FACT-Hep, DiPcare-Q and health inequality related questions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glycaemic control, Continuous glucose monitoring