Name:

The Fenland Study

Parent study:

Public title: The Fenland Study- investigates the interaction between genetic and lifestyle factors in determining obesity, diabetes and related metabolic disorders which present a considerable public health concern.

Scientific title: The Fenland Study- a population-based cohort study of the interaction between environment and genetic factors in determining obesity, insulin sensitivity and hyperglycemia.

Other names:

N/A

Description:

The Fenland Study looks at the influence of diet, lifestyle and genetic factors on the development of diabetes, obesity and other metabolic disorders with the aim of developing health strategies to prevent these conditions. The study is looking at 10,000+ people born between 1950 and 1975 from three regions in Cambridgeshire: Ely, Wisbech and Cambridge. The Fenland Study recruits male and female volunteers through participating GP surgeries, inviting people who meet specific inclusion criteria such as age.

In this study great attention is being given to the metabolic characterisation of volunteers, particularly sensitivity to the hormone insulin which is important in diabetes. A blood sample is taken which is assessed for glucose and blood fats such as cholesterol. Volunteers also have their response to glucose assessed. They consume a harmless sugary drink and their response is measured via another blood sample.

During their assessment, volunteers have a number of body measurements taken such as height and weight as well as an ECG to assess the health of their heart. We also use ultrasound and DEXA to measure fat levels (adiposity) in the body.

Volunteers also have their physical activity levels and diet accurately measured. This is partly done through a series of questionnaires relating to medical history, normal diet, physical activity and general lifestyle. Physical fitness is measured using a treadmill test to assess the amount of energy that they use when walking in a controlled environment. We then measure everyday physical activity for six days using a combined movement sensor and heart rate monitor, wrist worn accelerometer and GPS

Abstract:

The Fenland study is an observational cross-sectional cohort study designed to investigate how common genetic variations interact with our dietary and physical activity patterns to determine the overall level of body fat and its distribution around the body and key indicators of metabolic health. The aim of the study is to look at genetic, behavioural and environmental factors relating to obesity and diabetes in 12,000+ adults. Men and women born between 1950 and 1975 registered at participating GP practices in the Fenland and East Cambridgeshire area can participate. The study started in 2005 and is currently being extended to a second phase. The study is run from a central hub at Addenbrooke´s Hospital, Cambridge (UK)

Locations:

Cambridge Test Centre
Ely Test Centre
Wisbech Test Center

Keywords:

Diabetes, obesity, metabolic disorder, genetic, lifestyle, public health, cohort study, environment, insulin sensitivity, hyperglycemia, diet, physical activity, body fat, Addenbrooke´s Hospital, Medical Research Council, Cambridge University, Wellcome Trust grant 074548

Research areas:

Diabetes, obesity and other metabolic disorders

Research purposes:

The Fenland Study looks at the influence of diet, lifestyle and genetic factors on the development of diabetes, obesity and other metabolic disorders with the aim of developing health strategies to prevent these conditions.

Population:

Men and women born between 1950-1975 registered at participating GP practices.

Status:

Active collection of data currently underway.

Recruitment:

Currently recruiting.

Recruitment started in Cambridge in December 2004 and the first volunteer was measured in January 2005. The second site was opened at the North Cambridgeshire Hospital in Wisbech in February 2006 and a third was opened at the Princess of wales Hospital in Ely in March 2006. The 5000th volunteer was recruited on Friday the 20th of November 2009 and by 28 June 2009 10000 volunteers had been recruited across the eastern region.

Start date:

The study started 0n 2014/12/01

End date:

N/A

Links:

Title	URL
Study Web Site	http://www.mrc-epid.cam.ac.uk/research/studies/fenland/

Identifiers:

Identifier	Description
MRC Identifier (R Number)	R040416/008
ISRCTN72077169	ISRCTN code, assigned 30/08/2013
10.1186/ISRCTN72077169	DOI code
DRN055	DRN Number

Approvals required:

Approval	Details
Ref 04/Q0108/19	Cambridge Regional Ethics Committee. Approval Date: 11th May 2004.

Funding required:

Funding	Details
Grant	Wellcome Trust Grant, Ref: 074548 (UK) & Medical Research Council (UK)

Data access:

Data requests are submitted to the Fenland Steering Committee (FSC) for approval. A Data Request Form for submission to the Fenland Study is available and once completed should be sent in the first instance to datasharing@mrc-epid (or alternatively please print, complete, scan and submit using this PDF). The Senior Data Manager, Tony Webb, will manage the processing of your data request.

Data collected:

1. Oral glucose tolerance test
2. Measures of height, weight, waist and hip circumference and blood pressure
3. An ECG is carried out in order to provide information for exclusion from the treadmill test
4. Body fat is assessed by dual X-ray absorptiometry and ultrasonography
5. Habitual diet is assessed by questionnaire and biomarker analysis
6. Physical activity is assessed directly by using a combined sensor able to record heart rate and vertical accelaration. Individual calibration of heart rate and energy expenditure is carried out using a submaximal exercise test on a treadmill. Volunteers wear the sensor for 6 days following the visit to assess their habitual physical activity level

Sample size:

Initially set to 5000, extended to 10000 and extended again to 11500. Phase 2 will aim to see as many of those volunteers that participated in phase 1 with their consent to be re-contacted for future studies.

Sampling method:

Further description to follow

Participation type:

Participants opt in to the study and can opt out at any point.

Inclusion criteria:

Men and women born between 1950-1975 registered at participating GP practices

Exclusion criteria:

1. Diagnosed diabetes
2. Psychotic illness
3. Terminal illness
4. Pregnancy
5. Unable to walk unaided

Current size:

The current cohort size for release 6 is just under 10500, with recruitment for release 7 having reached approximately 12400 so far, with recruitment still ongoing.

Accountable people:

Role	Name (follow link for contact details)
Chief Investigator	Prof Nick Wareham
Principle Investigator	Prof Simon Griffin
Principal Investigator	Dr Nita Forouhi
Principle Investigator	Prof Soren Brage
Study Coordinator	Richard Salisbury
Clinical Research Manager	Dr Jennifer Furman
Unit Senior Data Manager	Tony Webb

Methods of Contact:

Post, Email or phone

Data sources:

• Access overview study details by following the OVERVIEW link for a study
• Access the details of a studies data and releases by following the RELEASE link for a study
• Access the latest study data dictionary by following the DICTIONARY link for a study
• Access the study questionaiires by following the QUESTIONNAIRES link for a study

OVERVIEW

RELEASE

DICTIONARY

QUESTIONAIRES

Related parties:

Details to follow

Additional information:

N/A