Objective: To study differences of (adipo) cytokine spectra in visceral and peripheral adipose tissue and to study the effect of caloric restriction on (adipo) cytokine production of these different fat tissues.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: The effect of caloric restriction on (adipo)
cytokine production.
Secondary outcome
Differences of (adipo) cytokine spectra of visceral and peripheral adipose
tissue
Background summary
Rationale: Obesity is a risk for cardiovascular disease and mortality. One of
the mechanisms is inflammatory (adipo) cytokine production by visceral fat
tissue. (Adipo) cytokines enhance the inflammatory response in the arterial
wall and contribute to atherosclerotic disease.
Study objective
Objective: To study differences of (adipo) cytokine spectra in visceral and
peripheral adipose tissue and to study the effect of caloric restriction on
(adipo) cytokine production of these different fat tissues.
Study design
Study design: A randomised controlled single (investigator) blinded trial.
Intervention
Intervention (if applicable): Two groups, each 25 patients will be formed, one
group of patients being treated with 600 Kcal kCal restriction for 3 days
prior to surgery and one group treated with 2000 Kcal prior to surgery.
.
Study burden and risks
Sampling of a small specimen of peripheral and visceral fat tissue prolongs the
surgery time with a few minutes. 600 Kcal restriction prior to the surgery
could be experienced as cumbersome.
Reinier de Graaf weg 3 - 11
2600 GA Delft
NL
Reinier de Graaf weg 3 - 11
2600 GA Delft
NL
Listed location countries
Age
Inclusion criteria
1. Obese patients (BMI >27 Kg/m2)
2. Anyone planned for gallbladder surgery.
3. Informed consent signed by patient
4. Male and female patients aged 18 * 60 years
Exclusion criteria
1. Unwillingness to cooperate with the study procedures
2. History of an active malignancy
3. BMI <27 Kg/m2
4. ESR >20
5. Serum albumin <30 g/l at entry of the study
6. Treatment with hypolipidemic drugs
7. Treatment with anti- inflammatory drugs (including glucocorticosteroids,
Non-steroidal anti-inflammatory drugs)
8. Diabetes (fasting blood glucose >7.1 mmol/l)
9. Use of anti-diabetic agents
10. No written informed consent
11. pregnancy
Design
Recruitment
metc-ldd@lumc.nl
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 | NL31786.098.10 |