This week we have launched Phase 2 of the Fenland Study, with volunteers who participated in the first phase of the Fenland study returned to our testing centres in Cambridge and Ely for a second visit.
The Fenland Study, led by Chief Investigator Professor Nick Wareham, is designed to investigate the interaction between genetic and lifestyle factors in determining diabetes, obesity, and related metabolic disorders. These conditions are a considerable public health concern, but their causes and predicting factors are not completely understood. What makes the Fenland Study unique is the level of detail it collects about the health and lifestyle of participants, and objective measurement techniques used in the screening.
On Monday the BBC Radio Cambridgeshire Breakfast Show broadcast a report on the Fenland study, where reporter Jozef Hall spoke with research assistant Ben Brown and study volunteers Peter Nash and Joanne Welham during their visit to our testing centre at Addenbrooke’s Hospital in Cambridge, and which finished with presenter Dotty McLeod interviewing principle investigator Dr Nita Forouhi live on air. You can listen to a recording of the broadcast here.
On Thursday evening BBC Look East broadcast a report on the launch of Fenland Phase 2, which featured study volunteer Mark Cranwell and Fenland research assistant Colin Farr at our Ely Research Unit, as well as interviews with principal investigators Professor Simon Griffin and Søren Brage.
The information we collect in Phase 2 will be used to define how changes in and interactions between lifestyle, environmental, genetic and metabolic factors over time determine diabetes, obesity and other relevant health conditions. By improving our understanding of how these factors influence the risk of developing diabetes, obesity and related disorders over time, what we learn from this study will help to inform both health information and advice provided to individuals, and government policies that influence health.
Approximately 12,500 people from across Cambridgeshire took part in the first phase of the Fenland Study, and we are now sending invitations to participants who attended an initial Fenland Study visit between 2005 and 2014 and who agreed to be re-contacted, to participate in phase 2 of the Fenland Study. It is entirely up to participants to decide whether or not they wish to take part on Phase 2, but the more participants who return for phase 2 the better will be quality of the information the study provides.
We will not be inviting all participants back for a 2nd visit immediately, as at least 4 years need to have elapsed between the first and second visits. Participants in Phase 2 will visit one of our Research Units at either the Princess of Wales Hospital in Ely, the North Cambs Hospital in Wisbech or the Addenbrooke’s Hospital in Cambridge, whichever is most convenient. The study visit will be a single morning visit of 3 1/2 hours, and will repeat the measurements that were carried out during their first visit.
- Completing a questionnaire relating to their medical history, normal diet, physical activity and general lifestyle.
- Taking a blood sample to determine blood glucose and fat levels, and a test to determine whether they have type 2 diabetes. On arrival participants consume a harmless sugary drink and their response to the glucose in the drink is assessed through a second blood sample taken 2 hours later. If they have have been diagnosed with diabetes since their first visit, they are still eligible to take part, however, we will only take an initial blood sample and they will not need to consume the sugary drink. Blood samples will be stored for future research aimed at understanding the cause of diabetes and related disorders, and these will not be labelled with any personally identifiable information.
- Measuring their body composition, including measuring height, weight, hip and waist circumference, performing an ECG of their heart and taking blood pressure measurements. We use a DEXA scanner and ultrasound to assess their body composition.
- Measuring fitness. Firstly, we ask participants to rest by lying on a couch for 10 minutes. During this test we measure your resting energy expenditure by monitoring the air that they breathe. If they are eligible, we then ask them to walk on a treadmill for 16 minutes and if they can, to jog for 4 minutes. Alternatively, they may be asked to perform a self-paced walk test.
- Measuring physical activity level. Participants are given a combined heart rate and movement sensor weighing less than 10 grams, to wear continuously for 6 days and nights, at the end of which they return the monitor to us by freepost.
- In addition to the combined heart rate and movement sensor participants will be asked if they would like to wear one or two additional monitors; a Global Positioning System Receiver (GPS) which can be worn discreetly on their waist and an accelerometer that is worn on your wrist.
- We will also assess muscular strength by performing a hand grip strength test of both hands
Study volunteers have the right to opt out of any part of the screening process if they wish.
In addition to the above measurements, for Phase 2 we will also invite some participants to donate a blood sample for the generation of induced pluripotent stem cells (iPSCs) for research purposes. Pluripotent stem cells are cells early in a chain of development which have the potential to become different cell types, such as those in the liver, pancreas or other organs. We are able to induce these cells from circulating white blood cells. We can then use the experimentally derived different cell types to investigate pathways that link our genetic profiles with metabolic disease. The benefit of this approach is that it allows the study of different cell types without the need for direct sampling, which would otherwise require invasive procedures such as, for example, endoscopy or needle biopsies. The cells we will generate will not be of direct benefit to participants or anyone else in the treatment of disease and will only be used for experimental research purposes.
We would like to take this opportunity to thank the more than 12,ooo volunteers who participated in the Fenland Study over the past decade, by participating they have already made a huge contribution to medical research, and we hope to see a many of them as possible again over the next few years as Phase 2 gathers pace.