Rode Kruis Ziekenhuis
Beverwijk, North Holland, 1942 LE, Netherlands
NCT Number: NCT02206256
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.
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Notify Me18 year–65 year
Female
Interventional
Phase 4
Beverwijk, North Holland, 1942 LE, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
Other names: purified fish oil, omega-3 fatty acids, eicosapentoenoic acid (EPA), docosahexaenoic acid (DHA)
A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.
Time frame: baseline, after treatment
liver volume of the left hepatic lobe measured by MRI
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
IL-6, IL-10, TNF-alpha
Time frame: Biopsies during gastric bypass surgery
Time frame: 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)
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
ACTH stimulation test
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
IL-6, IL-10, TNF-alpha and C-reactive protein
Time frame: During gastric bypass surgery
Surgeons fill out a questionnaire after the gastric bypass surgery
Time frame: After the pre-operative treatment
Questionnaire
Medical Center Alkmaar
Other
Acronym: OLIVIER
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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