Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04655456 |
| Other study ID # |
Manchester1 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2007 |
| Est. completion date |
November 20, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
University of Manchester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Background: measuring the prevalence of malnutrition, frailty and sarcopenia in same group of
older adults is effective in understanding the relation between these conditions. This could
support diagnosing, treatment and prevention in future practice. The research is aiming to
measure the estimate prevalence of malnutrition, frailty, sarcopenia and their overlap in
older adults, using the UK Biobank. In addition, it will aim to compare the two models of
frailty the phenotype and deficit accumulation using the UK Biobank database, as data
comparing these models is limited.
Methods/design: This is a cross-sectional study design that will use the UK Biobank database,
which includes 381,000 participants males and females, aged 50 years and above, who completed
the UK Biobank baseline assessments were included that is a subset from the main sample size
from the UK Biobank. For baseline, details of participant's characteristics will be included.
All three conditions will be identified as malnutrition by using GLIM criteria, while frailty
by using two models; the first model will be the 36 deficits model and phenotype model.
Finally, sarcopenia condition will be judge according to EWGSOP standard. All these models
will be determining the feasibility to apply it using the available database in the UK
Biobank.
Discussion: This proposed study will help in understanding the relation between malnutrition,
frailty and sarcopenia. As in worldwide, there is little published research on the overlap
between malnutrition, frailty and sarcopenia. Despite definitions and diagnostic criteria
were developed for these conditions. There is conflict extend to the definitions and
identification criteria's. This study will use UK Biobank database to measuring the estimate
prevalence in older people and determine the overlap between three conditions.
Description:
The UK Biobank is a population-based study of a large prospective longitudinal cohort with
information on 500,000 people, who were aged 40-69 when recruited in 2006-2010 from England,
Scotland and Wales. The database includes demographic data, online questionnaires, X-rays and
scan image of (brain, heart, abdomen, bones and carotid artery), as well as urine and saliva
samples and blood biochemistry including: hormones and blood lipid. The online questionnaires
(about: diet, cognitive function, work history and digestive health). It aims to improve the
following: prevention, diagnosis and treatment for a broad number of diseases including
cancer, heart diseases, stroke, diabetes, arthritis, osteoporosis, eye disorders, depression
and forms of dementia. This detailed information on participants provide a resource for
investigators to conduct research related a particular diseases.
There are four phases of assessment in UK Biobank. The first phase was the UK Biobank Pilot
assessment that included 3798 participants from Stockport only in 2006. Then, the second
phase was the initial assessment visit that started in 2007 until 2010. This was the baseline
assessment and included approximately 500000 participants. After that, the third phase was
conducted and called the first repeat assessment visit which took place between 2012-2013 and
included 20346 participants. Lastly, the imaging visit which is considered the fourth phase
started in 2014 until present.
