Gambian bone and muscle ageing study
| ISRCTN | ISRCTN17900679 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17900679 |
| Secondary identifying numbers | N/A |
- Submission date
- 09/06/2017
- Registration date
- 17/06/2019
- Last edited
- 21/01/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Musculoskeletal diseases are diseases of the bones, muscles and their attachments (e.g. joints and ligaments). They form a major part of the current global non-communicable (not caused by infections) disease burden. By 2050, the vast majority of the world’s ageing population will live in low- and middle-income countries. There is very little information about musculoskeletal diseases from countries in sub-Sarahan Africa. This study is investigating men and women from a poor, subsistence farming community of The Gambia, West Africa. The study is designed to measure changes in bone and muscle health using state of the art techniques and identify possible ways of preventing bone and muscle loss as people get older, and the accompanying risk of falls and fractures which lead to poor health, disability and premature deaths.
Who can participate?
Men and women aged 40 and over living in villages in the Kiang West area of The Gambia
What does the study involve?
Participants are invited to undergo measurements both in the MRC research facilities in The Gambia and whilst they are at home. After measurements have been made at the start of the study they are then seen every 1.5-2 years for follow-up measurements. The data collected includes measurements of bone and muscle strength, hormones and metabolites in urine and blood samples, dietary intake, and blood pressure. Questionnaires are used to obtain information on health, lifestyle, musculoskeletal pain, socioeconomic status, physical activity and reproductive history.
What are the possible benefits and risks of participating?
There are no direct benefits to the participants, other than participation in research aimed at improving health and informing public health nutrition policy in The Gambia and other countries. Participants who have results which may be clinically relevant and suggest previously undiagnosed health problems are referred to the study physician or nurse for initial follow up and then decisions are taken as to whether treatment or further investigation is needed. Ultimately, the findings from this study will contribute to the understanding of musculoskeletal health in populations transitioning from traditional to more western lifestyles. The results are also compared with those obtained from studies of older people in the UK.
Where is the study run from?
The study is being run by the Medical Research Council and takes place in rural villages in The Gambia, West Africa
When is the study starting and how long is it expected to run for?
April 2010 to December 2023
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Kate Ward
Contact information
Scientific
MRC Lifecourse Epidemiology
University of Southampton
Southampton General Hospital
Tremona Road
Southampton
SO16 6YD
United Kingdom
 ORCID ID |
0000-0001-7034-6750 |
|---|---|
| Phone | +44 (0)2380 777624 |
| kw@mrc.soton.ac.uk |
Study information
| Study design | Prospective longitudinal observational study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Longitudinal study |
| Study setting(s) | Community |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Gambian Bone and Muscle Ageing Study (GamBAS): a longitudinal observational study in men and women in rural Gambia |
| Study acronym | GamBAS |
| Study objectives | To characterise changes in bone and muscle outcomes and to identify possible preventative strategies for fracture and sarcopenia. |
| Ethics approval(s) | Approved 17/12/2010, Medical Research Council/Gambian Government Joint Ethics Committee (Clo MRC Laboratories, Fajara, P.0. Box 273, Banjul, The Gambia, West Africa; +220-4495919 or 4496 513; +220-4495442-6 ext. 2308), ref: 1222. |
| Health condition(s) or problem(s) studied | Musculoskeletal health |
| Intervention | Measurements are made at baseline and follow-up every 1.5-2 years. Methods include bone imaging (DXA and pQCT), muscle strength (jumping mechanography, grip strength), anthropometry, blood and urine biochemistry, blood pressure, and dietary intake. Questionnaires to obtain information on health, lifestyle, physical activity, socio-economic status, musculoskeletal pain, reproductive history. |
| Intervention type | Other |
| Primary outcome measure | 1. Bone mineral content (BMC) is measured using DXA measurements at baseline and follow-ups. 2. Areal bone mineral density (BMD) is measured using DXA at baseline and follow-ups. 3. Bone area is measured using DXA at baseline and follow-ups. 4. BMC is measured using peripheral quantitative CT (pQCT) at baseline and follow-ups. 5. Volumetric BMD is measured using pQCT at baseline and follow-ups. |
| Secondary outcome measures | 1. Bone shape and size by DXA and pQCT. 2. Muscle force/ strength Hand dynamometry for grip force: muscle force/ strength 3. Lateral vertebral assessment using DXA at baseline and follow-ups. 4. Regional and total fat and lean mass are measured using DXA at baseline and follow-ups. 5. Muscle ‘density’ and area are measured using pQCT at baseline and follow-ups. 6. Height (standing and sitting), demi-span and other limb dimensions, weight, mid-upper arm circumference (MUAC) and 4 skinfolds are measured at baseline and follow-ups. 7. Standing, sitting and lying blood pressure is measured at baseline and follow-ups. 8. Fasting blood, 2-h fasting urine, 24-h urine: including for markers of calcium, phosphate and vitamin D metabolism, bone metabolism, liver and kidney function, clinical chemistry, sex hormones are measured at baseline and follow-ups. 9. Dietary assessment is conducted at baseline and follow-ups. |
| Overall study start date | 01/04/2010 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | Stratified sampling to ensure recruitment of equal numbers of men and women in each of eight, 5-year age bands: 40-44, 45-49, 50-54, 55-59, 60-64, 65-69, 70-74, 75 years and over; 240 women and 240 men, totalling 480 participants. |
| Total final enrolment | 488 |
| Key inclusion criteria | 1. Men and women aged 40 and above 2. Able to give informed consent |
| Key exclusion criteria | 1. Pregnant or lactating women 2. Individuals deemed too physically frail or incapable, due to existing disability or chronic illness to attend for measurements |
| Date of first enrolment | 17/10/2011 |
| Date of final enrolment | 31/12/2012 |
Locations
Countries of recruitment
- Gambia
Study participating centre
Gambia
Sponsor information
Research council
14th Floor
One Kemble Street
London
WC2B 4AN
United Kingdom
| Phone | +44 (0)1793 416 200 |
|---|---|
| corporate@headoffice.mrc.ac.uk | |
"ROR" |
https://ror.org/03x94j517 |
Funders
Funder type
Research council
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 | 31/12/2021 |
|---|---|
| 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 | Papers from baseline and first follow up are in preparation. |
| 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? |
|---|---|---|---|---|---|
| Other publications | baseline data | 31/08/2017 | 11/06/2019 | Yes | No |
Editorial Notes
21/01/2022: The following changes have been made:
1. The study contacts were updated.
2. The overall trial end date has been changed from 31/12/2020 to 31/12/2023.
3. The plain English summary has been updated to reflect the changes above.
18/01/2022: The contacts were updated.
11/06/2019: Trial's existence confirmed by the Medical Research Council/Gambian Government Joint Ethics Committee.
