Morbid Obesity
Conditions
Brief summary
Gastric bypass surgery is the gold standard in bariatric surgery and is a successful method to reduce weight in morbidly obese subjects. Patients qualified for gastric bypass surgery are routinely pre-treated with a low calorie diet in order to reduce liver volume and to facilitate the approach of the gastro-oesophageal junction. Pre-treatment with omega-3 fatty acids has similar effects on liver volume, but a prospective comparison of both treatments has not been performed yet. Morbidly obese patients respond differently to surgical stress, due to a number of factors. First, obesity is associated with a low-grade inflammatory state induced by an increased amount of macrophages in adipose tissue. This state is associated with higher levels of pro-inflammatory cytokines in serum and with a less adequate immune response to infections. Second, obesity is associated with an altered cortisol metabolism possibly related to adrenal insufficiency. This could play an important role in the altered response to surgical stress and postoperative complications in obese subjects. Third, obesity is associated with altered erythrocyte function, including decreased erythrocyte deformability and increased aggregation, factors contributing to an impaired microcirculation. This study has a number of different aims. First, we will compare pre-treatment with the standard low calorie diet with omega-3 fatty acids on liver volume in patients qualified for gastric bypass surgery because of morbid obesity. Second, we will investigate the effect of omega-3 fatty acids on immune function, the low-inflammatory state of adipose tissue, the stress response of obese subjects before and erythrocyte function. Third, we will investigate the effect of gastric bypass surgery by comparing values before surgery with values on the first postoperative day and 6 months after surgery regarding to immunological parameters, stress response and erythrocyte function.
Interventions
DRUGOmega-3 fatty acid capsules
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
BEHAVIORALLow calorie diet
A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.
Sponsors
Medical Center Alkmaar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Females undergoing laparoscopic gastric bypass surgery because of morbid obesity * Age between 18 and 65 years * Able to fit in the MRI * Written informed consent
Exclusion criteria
* Pregnancy * Diabetes mellitus type 1 * Current history of inflammatory, infectious or malignant disease * Daily use of anti-inflammatory drugs * Contra-indications for MRI imaging * Contra-indications for the use of omega-3 fatty acids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver volume | baseline, after treatment | liver volume of the left hepatic lobe measured by MRI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Macrophage infiltration in omentum fat biopsies | Biopsies during gastric bypass surgery | — |
| Erythrocyte function | baseline, day of surgery, postoperative day 1, follow up 6 months | Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer) |
| Cortisol response | baseline, operation day, postoperative day 1, follow up 6 months | ACTH stimulation test |
| Peri-operative ex vivo LPS stimulated cytokine production capacity | baseline, operation day, postoperative day 1, follow up 6 months | IL-6, IL-10, TNF-alpha |
| Assessment of the approach of the gastro-oesophageal junction | During gastric bypass surgery | Surgeons fill out a questionnaire after the gastric bypass surgery |
| Patient satisfaction with intervention | After the pre-operative treatment | Questionnaire |
| Serum parameters of inflammatory response | baseline, operation day, postoperative day 1, follow up 6 months | IL-6, IL-10, TNF-alpha and C-reactive protein |
Countries
Netherlands
Outcome results
None listed