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
| ISRCTN | ISRCTN72077169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72077169 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/05/2013
- Registration date
- 30/08/2013
- Last edited
- 16/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
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. Follow-up visits take place at least 4 years later, in chronological order, so those that took part first of all were invited first.
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. There is no risk involved in 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?
December 2004 to March 2021
Who is funding the study?
Medical Research Council (MRC) (UK)
Who is the main contact?
Nick Wareham
Contact information
Scientific
MRC Epidemiology Unit
Level 3, Institute of Metabolic Science
Box 285
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Study information
| Study design | Single-centred observational cross-sectional cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study 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(s) | Current ethics approval as of 01/07/2022: Phase 1: Approved 11/05/2004, Cambridge Regional Ethics Committee, ref: 04/Q0108/19 Phase 2: Approved 05/07/2014, NRES East of England – Cambridge East Research Ethics Committee, ref: 14/EE/0122 COVID 19: Approved 30/06/2020, South West - Cornwall & Plymouth Research Ethics Committee, ref: 20/SW/0100 Previous ethics approval: Phase 1: Cambridge Regional Ethics Committee, 11/05/2004, ref: 04/Q0108/19 Phase 2: NRES East of England – Cambridge East Research Ethics Committee, 05/07/2014, ref: 14/EE/0122 |
| Condition | Diabetes, obesity and other metabolic disorders |
| Intervention | Phase 1: 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 acceleration. 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 Added 13/05/2019: Phase 2: Follow-up visits took place at least 4 years after Phase 1, in chronological order, so those that took part first of all were invited first. |
| Intervention type | Other |
| Primary outcome measure | 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 study start date | 01/12/2004 |
| Overall study end date | 31/03/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 10,000 |
| Total final enrolment | 10092 |
| Participant inclusion criteria | Men and women born between 1950-1975 registered at participating GP practices |
| 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
- England
- United Kingdom
Study participating centre
CB2 0QQ
United Kingdom
Sponsor information
University/education
c/o Carolyn Read
Research Governance Officer
School of Clinical Medicine
Cambridge
CB2 0QQ
England
United Kingdom
| Website | http://www.cam.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/013meh722 |
Funders
Funder type
Charity
Private sector organisation / International organizations
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/03/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/10/2015 | Yes | No | |
| Other publications | 14/03/2023 | 16/03/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/03/2023: Publication reference and total final enrolment added.
01/07/2022: The following changes have been made:
1. The ethics approval has been updated.
2. The overall trial end date has been changed from 31/07/2020 to 31/03/2021 and the plain English summary has been updated to reflect this change.
3. The trial website has been added.
03/04/2020: The overall end date was changed from 31/03/2020 to 31/07/2020.
13/09/2019: Publication and dissemination plan and IPD sharing statement added.
13/05/2019: The following changes were made to the trial record:
1. Sponsor contact details, ethics approval details and interventions were updated.
2. The overall trial end date was changed from 31/12/2014 to 31/03/2020.
16/01/2017: Publication reference added.
