Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02206256
Study type	Interventional
Source	Medical Center Alkmaar
Contact
Status	Completed
Phase	Phase 4
Start date	November 2014
Completion date	November 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03657927` - A Comparison of McGrath MAC Versus C-MAC Videolaryngoscopes in Morbidly Obese Patients	N/A
Recruiting	`NCT04934826` - Comparison of the Absorption of Hydrolyzed or Intact Proteins in Morbid Obese Patients After the Roux Y Gastric Bypass	N/A
Completed	`NCT03181347` - The Microbiology of Bariatric Surgery	N/A
Completed	`NCT03886870` - Obesity, Lifestyle and Work Intervention	N/A
Active, not recruiting	`NCT04433338` - The PREBA Study: Effect of Preoperative Weight Loss With a 14-day Low-calorie Diet on Surgical Procedure and Outcomes in Patients Undergoing RYGB Surgery	N/A
Completed	`NCT03553849` - Utilization of Very Low Calorie Diet in Obese General Surgery Patients	N/A
Completed	`NCT05854875` - Diabetes Remission After RYGBP and RYGBP With Fundus Resection	N/A
Not yet recruiting	`NCT03203161` - Registry on Obesity Surgery in Adolescents
Not yet recruiting	`NCT03601273` - Bariatric Embolization Trial for the Obese Nonsurgical	Phase 1
Recruiting	`NCT02129296` - Intragastric Balloon, Air Versus Fluid Filled: Randomized Prospective Study	Phase 1/Phase 2
Active, not recruiting	`NCT01564732` - Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding	N/A
Completed	`NCT02033265` - Ultrasound-Guided Axillary Brachial Plexus Block: Influence of Obesity
Completed	`NCT01963637` - Gastric Volumetry by Gastric Tomodensitometry With Gas	N/A
Not yet recruiting	`NCT01652105` - Randomized Trial of Preoperative Diets Before Bariatric Surgery	N/A
Completed	`NCT01149512` - Outcomes of the Adjustable Gastric Band in a Publicly Funded Obesity Program	N/A
Terminated	`NCT01759550` - Prospective Case-Series of Ligasure Advance Pistol Grip and LigaSure Blunt Tip
Completed	`NCT01955993` - Fentanyl Metabolism in Obese Adolescents	N/A
Recruiting	`NCT01685177` - Single Anastomosis Duodeno-Ileal Bypass vs Standard Duodenal Switch as a Second Step After Sleeve Gastrectomy in the Super-Morbid Obese Patient	N/A
Completed	`NCT00624624` - Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism	N/A
Completed	`NCT02414893` - Hunger/Satiety's Physiopathologic Study in Morbidly Obese Patients	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Omega-3 Fatty Acids in Bariatric Gastric Bypass Surgery: Effect on Liver Volume, Immune Response and Erythrocyte Function — OLIVIER

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms