Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/05/2013
Date assigned
30/08/2013
Last edited
09/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The aim of the study is to look at genetic, behavioural and environmental factors relating to obesity and diabetes in a group of 10,000 people born between 1950 and 1975.

Who can participate?
Men and women born between 1950 and 1975 registered at participating GP practices in the Fenland and East Cambridgeshire area.

What does the study involve?
Interested applicants are invited to attend for a single visit at one of the MRC Epidemiology Unit testing centres. The visit lasts about three hours and includes measures of metabolic health, diet and other lifestyle patterns, body composition, fitness and physical activity. There is no risk involved in the tests.

What are the possible benefits and risks of participating?
The possible benefits of participating are receiving a very thorough health check including a test for diabetes and measurement of blood cholesterol. With the participants’ permission their results will be passed to their GP and they will receive detailed individual feedback on the results from the tests.

Where is the study run from?
Addenbrooke's Hospital (UK).

When is the study starting and how long is it expected to run for?
The study started in December 2004 and will run until December 2014.

Who is funding the study?
The study is funded by the Medical Research Council (MRC) (UK).

Who is the main contact?
Nick Wareham
Addenbrooke's Hospital (UK).

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nick Wareham

ORCID ID

Contact details

MRC Epidemiology Unit
Level 3
Institute of Metabolic Science
Box 285
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

Acronym

The Fenland study

Study hypothesis

The study is 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.

Ethics approval

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

Study design

Single-centred observational cross-sectional cohort study.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetes, obesity and other metabolic disorders

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The study is 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. All outcomes are measured at the one-off visit. There are no follow-up visits involved in this study.

Secondary outcome measures

N/A

Overall trial start date

01/12/2004

Overall trial end date

31/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

10,000

Participant exclusion criteria

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

Recruitment start date

01/12/2004

Recruitment end date

31/12/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Epidemiology Unit
Cambridge
CB2 0QQ
United Kingdom

Sponsor information

Organisation

University of Cambridge (UK)

Sponsor details

c/o James Sylvester
MRC Epidemiology Unit
Level 3
Institute of Metabolic Science
Box 285
Addenbrooke's Hospital,Hills Road
Cambridge
CB2 0QQ
United Kingdom

Sponsor type

University/education

Website

http://www.cam.ac.uk/

Funders

Funder type

Charity

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes