Primary objective:Increase in left ventricular ejection fraction after bariatic surgerySecundary objectives:Reduction of paracardial fat after bariatic surgeryReduction of visceral abdominal fat after bariatic surgeryReduction of hepatic steosis…
ID
Source
Brief title
Condition
- Other condition
- Heart failures
- Gastrointestinal therapeutic procedures
Synonym
Health condition
(Morbide) Obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Increase in left ventricular function after bariatic surgery.
The most important variables are not clear/uncertain due to a lack of relevant
literature regarding the primary objective in combination with a MRI of the
heart.
Secondary outcome
Differences in certain levels in blood samples
Reduction of paracardial fat after bariatic surgery
Reduction of visceral abdominal fat after bariatic surgery
Reduction of hepatic steosis after bariatic surgery
Increase in compliance of the thoracic aorta
Anthropometric measurements before and after bariatic surgery
Differences in measurements between the types of bariatic surgery
Background summary
In the medical world it is known that there are multiple pathophysiological
processes within the body of morbid obese patients. Due to these processes
people gain significantly amounts of weight which can cause changes in
metabolism. One of the best known change is de progressive resistance to
insulin which cause (non) insulin dependent diabetes mellitus type II. It is
also proven that obesity causes hypertrophy of the left ventricle of the heart
and a diminished left ventricular ejection fraction (LVEF) and more cardiac
morbidity and mortality.
To objectivate cardial (dys)function there has to be a validated method to
measure one of the most important functional paremeters: LVEF.
There are multiple methods like trans thoracic sonography, transesophageal
sonography, nuclair imaging and MRI. The method of choice is proven to be an
MRI of the heart, which (somestimes with the help of iv-contrast) can measure
functional parameters, dimensions of the left ventricle, left ventricular mass,
left ventricular ejection fraction and other (patho)physiological processes.
Bariatric surgery triggers an post operative recovery of the diminished left
ventricular function and causes a decrease of mass and diameter of the left
ventricle, thus a decrease of left ventricular hypertrofy and a increase of
LVEF. In this proces, the decrease in BMI seems to be correlated with the
amount of decrease in left ventricular mass. After one year there could be a
total recovery of diastolic and systolic dysfunction and aortic compliance. The
glucose metabolism can even recover significantly to recover completely after
substantial weight loss.
Possible explenations of improvement in LVEF may concern a regression of direct
toxic effects in adipose patient upon cardiomyocyts and an improved
haemodynamics after weight loss. These improvements can be of such order it may
provide a alternative for heart transplant in extreme obese patients.
Annually a total of 400 bariatric surgeries is performed at Maasstad Hospital,
Rotterdam, The Netherlands. Mostly it concerns a sleeve gastrectomy or a
Roux-en-Y gastric bypass. The most post operative finding is loss of body
weight, but also a drop in insulin resitance is seen.
Study objective
Primary objective:
Increase in left ventricular ejection fraction after bariatic surgery
Secundary objectives:
Reduction of paracardial fat after bariatic surgery
Reduction of visceral abdominal fat after bariatic surgery
Reduction of hepatic steosis after bariatic surgery
Increase in compliance of the thoracic aorta
Anthropometric measurements before and after bariatic surgery
Differences in measurements between the types of bariatic surgery
Study design
The study will be prospective observational amongst obese patients who are
qualified for bariatric surgery. A MRI of the heart will be performed once
before surgery and three times after bariatic surgery (3, 6, 12 monhs). With
each MRI, blood samples will be taken to investigate the relation of chemical
and endocrinological processes in relation with the left ventricular ejection
function.
Study burden and risks
Burden:
1. Four times a MRI of the heart (once before bariatric surgery, three times
after batiatric surgery after 3, 6 and 12 months).
2. Fout times blood samples (with a maximum of 4 times 10 cc)
Risks:
1. Sensations when stepping into the magnetic field of the MRI (iron taste,
vertigo)
2. Small haematoma after a vena punction.
Maasstadweg 32
Rotterdam 3079DZ
NL
Maasstadweg 32
Rotterdam 3079DZ
NL
Listed location countries
Age
Inclusion criteria
Age between 18 and 60 years
BMI > 40 kg/m2 or BMI > 35 kg/m2 with comorbidity (DM, lung problems, joint complaints)
Several registrated efforts of weightloss, guarded by a dietician
Exclusion criteria
Age < 18 and > 60 years
Personality disorders / alcohol or drugs abuse
< 5 years of adiposity
No serious attemps of weightloss
Obesity caused by hormonal of metabolic disorders, no willingness for analysis of such disorders or lifelong check-ups
Change in medication to prevent atherosclerosis (statins)
Diameter > 65 cm (MRI diameter)
Standard contra indications for MRI
Congenital heart disease, known cardiomyopathy, ischaemic heart disease, heart infarction, myocarditis.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL46652.101.13 |