Condition category
Nutritional, Metabolic, Endocrine
Date applied
29/03/2015
Date assigned
26/04/2015
Last edited
05/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Catherine Riva

ORCID ID

Contact details

University of Avignon
LaPEC
Avignon
84000
France
(33) 490162933
catherine.riva@univ-avignon.fr

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

MIcroparticles in PAThophysiology of OBesity

Acronym

MIPATOB

Study hypothesis

Role of the microparticles in the pathophysiolgy of obesity

Ethics approval

Farhat Hached Hospital Ethical Committee for research on humans in Tunisia, 11/01/2011

Study design

Observational study single-centre

Primary study design

Observational

Secondary study design

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Domain of adult obesity

Intervention

1. Anthropometrics (body measurements)
2. Biological parameters and microvascular function (e.g. blood pressure, pulse rate)

Intervention type

Other

Phase

Drug names

Primary outcome measures

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 trial start date

01/12/2011

Overall trial end date

30/12/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Adults with BMI ≥ 30kg/m²

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Total subject number = 410 ( 244 obese patients+166 control healthy subjects)

Participant 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

Recruitment start date

01/12/2011

Recruitment end date

30/12/2014

Locations

Countries of recruitment

Tunisia

Trial participating centre

University of Sousse
Faculty of Medicine
Sousse
4002
Tunisia

Sponsor information

Organisation

Sousse University

Sponsor details

Faculty of Medicine
Sousse
4002
Tunisia

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Sousse University Hospital (Tunisia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

EA4278 Unit of the University of Avignon (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes