Primary objective: to identify intra-individual changes of clinical and biochemical markers of AT characteristics before, and one year after bariatric surgery by:* Determining circulating AT derived biomarkers * Determining local AT biomarkers in…
ID
Source
Brief title
Condition
- Other condition
- Cardiac arrhythmias
Synonym
Health condition
eigenschappen van vetweefsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints
* AT mass, distribution and ratios (EAT, PAT,VAT)
* Circulating AT derived protein biomarkers, including: (1) inflammatory
markers, (2) adipocytokines, (3) oxidative stress markers, (4) growth and
remodelling markers, (5) markers representing AT metabolism.
* Circulating AT derived miRNAs
* Locally AT derived protein biomarkers, extracted from VAT. Markers similar to
those in circulation.
* Locally AT derived miRNAs extracted from VAT.
* Anthropometric measurements: height, weight, BMI, waist-circumference,
hip-waist ratio.
* Occurrence/absence of AF by an approved 7 days rhythm monitoring system.
* 1. Questionnaire about food and calorie intake: Diet journal for one week
using an Internet application (Eetmeter, Stichting Voedingscentrum Nederland,
The Hague, Netherlands).
* 1. EPIC Norfolk Food Frequency Intake Questionnaire
* 2. International Physical Activity Questionnaire.
Secondary outcome
Clinical data: data is gathered on the patients history and medication use and
AF associated factors such as coronary artery disease, gender, age,
hypertension, medication use and response, smoking, BMI, kidney function and
laboratory parameters.
Background summary
Obese patients experience more AF occurrences and recurrences compared to
patients with a healthy BMI. Clinically, weight loss in obese patients with AF
increases AF freedom in a dose-dependent manner, resulting in 50% absence of AF
in patients losing >10% bodyweight. These results present a significant
relationship between obesity and AF. However, details on the mechanisms
underlying this relationship and on reversible pathological factors remain to
be discovered.
Therefore, we designed a study in which obesity along with adipose tissue (AT)
characteristics are studied upon drastic weight loss. Currently, how drastic
weight loss reduces the pro-arrhythmic effect is unknown. AT characteristics
before and after weight loss will be compared to AT characteristics from
patients with and without AF, obtained from other studies. In this study we aim
at investigating the alterations in cardiac AT mass, AT activity and
anthropometrics that occur upon drastic weight loss, and at understanding how
certain of these fat characteristics predispose to AF.
Study objective
Primary objective: to identify intra-individual changes of clinical and
biochemical markers of AT characteristics before, and one year after bariatric
surgery by:
* Determining circulating AT derived biomarkers
* Determining local AT biomarkers in visceral AT (embryological is VAT similar
to EAT)
* Determining distribution, amount and ratios of local AT depots: EAT, PAT,
EAT/VAT
* Determining anthropometrics: fat percentage, BMI, waist-hip ratio
* To link these characteristics (before and after weight loss) to those from
patients with and those without AF. We will use the on-going studies MARK AF
(investigating defining fibrosis biomarkers in blood and atrial tissue from AF
patients; NL 50069.018.14) and PREDICT AF (investigating biomarkers for
fibrosis formation in blood and left atrial tissue in patients without AF; NL
50754.018.14).
Secondary objectives:
1. Determining AF presence through rhythm monitoring before surgery and during
follow-up
2. To link AT activity and other AT characteristics to AF occurrence in
patients from this study, before and after weight loss (in these relatively
few AF patients). These two do not belong to primary objective since we assume
that the AF prevalence in this cohort will not be high enough. In this non-
systematically screened cohort, the AF prevalence is thought to be +/- 3%
Study design
This exploratory study will be performed in patients undergoing bariatric
surgery. Patient data and material will be obtained during one visit before
surgery, during surgery, at 6 months follow-up and at 12 months follow-up. Fat
samples will only be extracted at baseline, while cardiac imaging, rhythm
monitoring, ECG, clinical characteristics, blood samples and questionnaires
will be obtained both pre-surgery and during the follow-up visits.
Study burden and risks
AF is responsible for up to one-third of ischemic strokes. AF often goes
under-diagnosed in the general population, known as subclinical AF (SCAF). In
comparison to controls with a healthy BMI (18,5-25), obese patients have an
increased risk on developing AF. These patients may therefore extra benefit
from routinely rhythm monitoring. Participation and follow-up could result in
early detection of SCAF. This in turn could prevent severe, AF related
complications as CVA from occurring, since proper anticoagulant treatment can
be provided immediately after AF detection.
Apart from the combined regular follow up moments, patients will be asked to
comply to 2 additional physician attendances. During a visit patients will
undergo multiple investigations to reduce the amount of needed visitations and
thereby reducing patienr burden. During these visits, 2 ultra low dose CT scans
will be done (1,2 mSv each). During previous studies in the OLVG-west,
extracting adipose tissue biopsies during surgery did not come with
complications. A possible complication would be a bleeding, however this
complication has only be described for percutaneous needle biopsies.
Additionally, a potential risk comes with the ultra low CT scan, related to the
radiation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patient undergoing bariatric surgery (BMI above 35)
Age above 40
Exclusion criteria
taking 2 or more antihypertensiva
taking metformine for diabetes
heart diseases, for example myocardinfarct in past
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 | NL62056.018.17 |