Circulating microparticles in obesity
| ISRCTN | ISRCTN22061598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN22061598 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/03/2015
- Registration date
- 26/04/2015
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
Obesity is a term used to describe somebody who is very overweight, with a lot of body fat. It's a common problem, estimated to affect around one in every four adults and around one in every five children aged 10 to 11 in the UK. People who are obese are at risk of a number of serious and potentially life-threatening conditions, such as disease of the heart or blood vessels (cardiovascular disease). Atherosclerosis is a serious condition where arteries become clogged up with fatty substances known as plaques. Plaques make the arteries harden and narrow, which restricts blood flow and can cause damage to organs by stopping them from working properly. They can also lead to blood clots which can trigger a stroke or heart attack. Atherosclerosis is the stage before cardiovascular disease, and it does not usually have symptoms until it is advanced and a person’s blood circulation is already restricted or blocked. When it is diagnosed at this late stage it is termed cardiovascular disease. There are a lot of studies looking into how diseases of the blood vessels can be diagnosed even earlier. A key process thought to be a precursor to atherosclerosis is endothelial dysfunction, which is an inflammation of the inner lining of the blood vessels. Endothelial dysfunction disrupts the normal functions of the blood vessels and is caused by various factors, such as smoking and being overweight. Endothelial function can be greatly improved by making lifestyle changes such as stopping smoking, exercising and losing weight. However, clinicians want to have an easy and accurate way of diagnosing endothelial dysfunction in patients early on. This will also allow them to advise patients of lifestyle changes that may be able to halt, or reverse, disease progression. Biomarkers (biological markers) are molecules that come from cells which can be found circulating in the blood. Scientists hope to use these biomarkers as a way of detecting changes in a person’s body at the very earliest stages of disease. The aim of this study is to investigate the content and structure of biomarkers called microparticles found in the blood of obese patients. The aim is to see whether these microparticles might be a reliable indicator of endothelial disease.
Who can participate?
Adults diagnosed as obese.
What does the study involve?
Participants have their body measured and blood samples taken. Various simple tests are used to determine cardiovascular function.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Sousse University (Tunisia)
When is the study starting and how long is it expected to run for?
December 2011 to December 2014
Who is funding the study?
Sousse University Hospital (Tunisia)
Who is the main contact?
Dr C Riva (scientific)
catherine.riva@univ-avignon.fr
Contact information
Scientific
University of Avignon
LaPEC
Avignon
84000
France
| Phone | (33) 490162933 |
|---|---|
| catherine.riva@univ-avignon.fr |
Study information
| Study design | Observational study single-centre |
|---|---|
| Primary study design | Observational |
| Secondary study design | |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | MIcroparticles in PAThophysiology of OBesity |
| Study acronym | MIPATOB |
| Study objectives | Role of the microparticles in the pathophysiolgy of obesity |
| Ethics approval(s) | Farhat Hached Hospital Ethical Committee for research on humans in Tunisia, 11/01/2011 |
| Health condition(s) or problem(s) studied | Domain of adult obesity |
| Intervention | 1. Anthropometrics (body measurements) 2. Biological parameters and microvascular function (e.g. blood pressure, pulse rate) |
| Intervention type | Other |
| Primary outcome measure | 1. Microvascular assessment of cutaneous blood flow performed by the laser Doppler flowmetry technique at diagnosis and after exercise training 2. Plasma microparticules quantification and characterization by Flow cytometry at diagnosis and after exercise training |
| Secondary outcome measures | 1. Circulating microparticles level 2. Informed written consent before inclusion |
| Overall study start date | 01/12/2011 |
| Completion date | 30/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Total subject number = 410 ( 244 obese patients+166 control healthy subjects) |
| Key inclusion criteria | Adults with BMI ≥ 30kg/m² |
| Key exclusion criteria | 1. History of hypertension, antihypertensive medication or elevated sitting blood pressure (systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg) 2. History of diabetes mellitus or fasting glucose > 7mmol/L 3. Any history or finding of cardiovascular disease, and/or undergone any cardiovascular procedures 4. Hyperlipidemia (total cholesterol > 6,7 mmol/L and/or triglycerides levels > 4,5 mmol/L) 5. Smoking 6. Consumption of any vasoactive medications or antioxidant supplements within the past 6 months |
| Date of first enrolment | 01/12/2011 |
| Date of final enrolment | 30/12/2014 |
Locations
Countries of recruitment
- Tunisia
Study participating centre
Sousse
4002
Tunisia
Sponsor information
University/education
Faculty of Medicine
Sousse
4002
Tunisia
"ROR" |
https://ror.org/00dmpgj58 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2016 | 17/12/2020 | Yes | No |
Editorial Notes
17/12/2020: Publication reference added.
