A Phase 4 interventional study of Omega-3 fatty acid capsules and Low calorie diet in Morbid Obesity, sponsored by Medical Center Alkmaar. Completed at 1 site in Netherlands. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by Medical Center Alkmaar · Phase 4, Interventional, and Treatment
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.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 62 is close to the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Medical Center Alkmaar is the lead sponsor of 19 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Low calorie diet 2 weeks pre-operatively
Behavioral: Low calorie diet
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
Drug: Omega-3 fatty acid capsules
2 times a day 1 capsule for 4 weeks before gastric bypass surgery
Also known as: 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.
Liver volume
liver volume of the left hepatic lobe measured by MRI
Time frame: baseline, after treatment
Peri-operative ex vivo LPS stimulated cytokine production capacity
IL-6, IL-10, TNF-alpha
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
Macrophage infiltration in omentum fat biopsies
Time frame: Biopsies during gastric bypass surgery
Erythrocyte function
Measurement of erythrocyte deformability and aggregation with LORRCA (laser-assisted optical rotational red cell analyzer)
Time frame: baseline, day of surgery, postoperative day 1, follow up 6 months
Cortisol response
ACTH stimulation test
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
Serum parameters of inflammatory response
IL-6, IL-10, TNF-alpha and C-reactive protein
Time frame: baseline, operation day, postoperative day 1, follow up 6 months
Assessment of the approach of the gastro-oesophageal junction
Surgeons fill out a questionnaire after the gastric bypass surgery
Time frame: During gastric bypass surgery
Patient satisfaction with intervention
Questionnaire
Time frame: After the pre-operative treatment
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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