To investigate the relationship between C3 and vitamin D in adipose tissue and serum in morbidly obese subjects and in subjects who lost weight due to bariatric surgery.
ID
Source
Brief title
Condition
- Other condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Health condition
Morbide obesitas
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To analyze the effect of weight loss on the relationship between concentrations
of C3 and vitamin D in visceral and subcutaneous adipose tissue and serum.
Secondary outcome
To analyze the relation of vitamin D and C3 with general markers of
inflammation and classic cardiovascular risk factors in adipose tissue and
serum and to analyze the effects of weight loss on these relations. To
investigate acute changes in post-operative serum C3 levels in obese and
non-obese subjects.
Background summary
There is increasing evidence that the immune system is closely linked to
metabolic pathways regulating adipose tissue biology, thereby influencing
morbid obesity and obesity-related diseases. However, the precise link between
metabolism and immunology remains unknown. Both, complement C3 and vitamin D
have been associated to inflammation and metabolism in obesity. Elevated C3
levels are associated with the metabolic syndrome, dyslipidemia and insulin
resistance. Unpublished data from our clinic show a negative correlation
between C3 and vitamin D. The aim of this study is to investigate the biology
of vitamin D and C3 in serum and adipose tissue and to investigate the relation
of C3 and C3-resistance with inflammation and metabolism in obese subjects.
Study objective
To investigate the relationship between C3 and vitamin D in adipose tissue and
serum in morbidly obese subjects and in subjects who lost weight due to
bariatric surgery.
Study design
A single center cross-sectional and longitudinal study.
Intervention
ASSISI-2: vitamin D supplementation versus placebo during a 12 weeks
preoperative period.
Study burden and risks
After informed consent obese subjects will visit the outpatient department to
undergo the standard bariatric protocol. In the first sub-study, approximately
30 mL of extra blood needs to be collected from each subject during the
standard pre- and postoperative venipuncture and one day postoperative. Extra
venipuncture will be performed in both lean and obese subjects on the day of
admission and 7 days postoperatively. During preoperative screening and
standard follow-up additional echocardiography and IMT and PWV measurement will
be performed. During surgery two adipose tissue samples will be collected; one
subcutaneous of 3 grams and one visceral sample of 5 grams. No adverse effects
are to be expected during the collection of the samples. When participating
subjects need to undergo elective cholecystectomy after the bariatric
intervention new adipose tissue samples will be collected. The follow-up period
will be 5 years.
Kleiweg 500
Rotterdam 3045PM
NL
Kleiweg 500
Rotterdam 3045PM
NL
Listed location countries
Age
Inclusion criteria
Scheduled for bariatric surgery (which means BMI >40 or BMI>35 with comorbidity)
Scheduled for laparoscopic cholecystectomy (BMI <30)
Aged 18 or above
Given Informed consent
Exclusion criteria
Previous cholecystectomy
Any acute inflammatory disease within 6 weeks prior to surgery
Any immune modulating therapy within 6 weeks prior to surgery
Patients planned for bariatric surgery and cholecystectomy 'en bloc'
Patients unable to understand and/or read the given information
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL47891.101.14 |
| OMON | NL-OMON28337 |