Status: Ongoing
First registered on:
03/04/2018
Last updated on:
04/04/2018
1. Study identification
EU PAS Register NumberEUPAS23454
Official titleLongitudinal Analyses of Body Mass Index and Risk of Parkinson's Disease in 2 million people over 2 decades
Study title acronymBMI and Parkinson´s disease
Study typeObservational study
Brief description of the studyPrevious research suggests that people who are overweight or obese may have a higher risk of developing Parkinson’s disease than people with normal weight, while other studies show no such association. The objective of this study is therefore to investigate the association between BMI and risk of Parkinson’s disease. A cohort will be derived from CPRD of people aged 40 years or older with a first BMI recording between 1992 and 2007. People with a prior record of Parkinson’s disease or dementia will be excluded. Incidence rates of Parkinson’s disease will be calculated for each BMI category using Poisson regression, adjusting for differences in patient characteristics and allowing for competing risks with a novel approach. This study will provide information from a very large number of people (2 million) with a sizeable amount of follow-up data in a representative sample. The findings will therefore provide important information to help clarify the relationship between BMI and Parkinson’s disease to inform preventative and therapeutic strategies for Parkinson’s disease.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)?
Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsOXON
Department/Research groupOXON Epidemiology
Organisation/affiliationOXON Epidemiology Ltd.
Details of (Primary) lead investigator
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres
In total how many centres are involved in this Study?2
Countries in which this study is being conducted
International study
Spain
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed20/07/201620/07/2016
Start date of data collection20/07/201620/07/2016
Start date of data analysis15/09/201615/09/2016
Date of interim report, if expected
Date of final study report17/09/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherNo funding100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Qizilbash MBChB MRCP(UK) BSc MSc DPhil(Oxon.)
First name Nawab
Address line 1Calle Dr. Fleming 51
Address line 2
Address line 3
CityMadrid
Postcode28036
CountrySpain
Phone number (incl. country code)34-913459395
Alternative phone number34-629846059
Fax number (incl. country code)34-913459394
Public Enquiries
Title Professor
Last name Pocock
First name Stuart
Address line 1London School of Hygiene & Tropical Medicine
Address line 2Keppel Street
Address line 3
CityLondon
PostcodeWC1E 7HT
CountryUnited Kingdom
Phone number (incl. country code)442076368636
Alternative phone number
Fax number (incl. country code)442076372853
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Obesity
Parkinson's disease
8. Population under study
Age
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects2000000
Additional information
2 million patients followed up over 2 decades.
Underweight (< 20 kg/m2): 106,716 people
Healthy weight (20-24.9 kg/m2):629,126 people
Overweight (25-29.9 kg/m2): 727,339 people
Obese (≥ 30 kg/m2): 489,406 people
With a median follow-up of 9·3 years, PD occurred in 11,616 people.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources registered with ENCePP
Sources of data
Routine primary care electronic patient registry
11. Scope of the study
What is the scope of the study?
Disease epidemiology
Risk assessment
Primary scope : Disease epidemiology
12. Main objective(s)
What is the main objective of the study?
The primary objective is to estimate the age-specific associations between BMI and Parkinson’s disease.
Secondary objectives are to assess the shape of the association and Identify potential modifiers and confounders of the risk.
The results will be usable for disease prediction models, patient management, the planning of trials, and help in hypotheses of pathophysiological mechanisms of PD
Are there primary outcomes?Yes
Parkinson´s disease
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Cohort study
14. Follow-up of patients
Will patients be followed up?Yes
Please describe duration of follow up
Up to 2 decades since BMI recording
15. Data analysis plan
Please provide a brief summary of the analysis method
We compared rates of PD across categories of BMI using Poisson regression models. Standardised incidence rates and rate ratios were either adjusted for age (in five-year bands) and sex, or further adjusted for the following covariates, measured at the time of index BMI. We used age at diagnosis, updating the data as people moved through the age categories during follow-up. Incidence rates were standardised to the age and sex distribution of the overall study population. We performed analyses to investigate whether the association between BMI and PD varied depending on the time from the index BMI measurement. We calculated the cumulative incidence of PD using the Kaplan-Meier estimator, with age as the underlying time scale.
We performed a sensitivity analysis to investigate whether our findings could be reasonably explained by competing risks usinga novel approach under a hypothetical scenario and using matching
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Not submitted
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documents
DescriptionDocumentLatest version
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
