Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass

Imperial College London30 enrolled

Overview

Losing weight before undergoing Roux-en-Y gastric bypass (RYGB) surgery may reduce liver fat content and size thereby improving surgical outcomes. This study aims to investigate whether a 2-week or 6-week pre-operative liquid formula low-calorie diet (LCD) reduces liver fat further than a conventional food diet prior to RYGB using magnetic resonance imaging (MRI). The hypothesis is that the 2-week and 6-week liquid formula LCD will reduce liver fat further than the conventional food pre-operative diet.

The morbidly obese subjects (BMI higher then 40 kg/m2) were randomised and assessed at baseline (week 0). After 2 weeks on a low-calorie diet (LCD), participants underwent either Roux-en-Y gastric bypass (RYGB) or continued with a LCD for 4 weeks.The participants will reassess at week 6.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Morbid Obesity Liver Fat

Interventions

Liquid formula low-calorie diet (LCD)DIETARY_SUPPLEMENT

The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.

Roux-en-Y gastric bypass (RYGB)PROCEDURE

Participant went through Roux-en-Y gastric bypass (RYGB) surgery

Control dietOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients undergoing Roux-en-Y gastric bypass at Imperial Weight Centre * aged 18 to 60 years * boby mass index of 35 to 55 kg/m2 Exclusion Criteria: * Claustrophobia * Pacemaker, metal implant, clips, implanted device, shrapnel or bullets, metal in eyes that precludes magnetic resonance imaging * Current pregnancy or breast feeding for females (as determined by a pregnancy test) * A full term pregnancy within the last year for females * Treatment with any medication that might affect the study outcomes * Haemorrhagic disorders and anticoagulant treatment * History of cancer, excluding skin cancer * History of severe or multiple allergies, severe adverse drug reaction or leucopenia * Smokers * Regular drinkers of more than three units of alcohol daily * History of, or current evidence of, abuse of alcohol or any drug substance, licit or illicit * Regular intake of over-the-counter (OTC) medication (other than the occasional paracetamol/aspirin) * Poor compliers or subjects unlikely to commit to the 26 week study duration * Blood donation within the 12 week period before the initial study dose * Use of monoamine oxidase inhibitors (MAOIs) as anti depressant

Locations (1)

Imperial Clinical research facility

London, Greater London, United Kingdom

Outcomes

Primary Outcomes

Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet

Intra-hepatocellular lipid content will be measured by magnetic resonance spectroscopy

Time frame: at 2 weeks or 6 weeks depending on group

Secondary Outcomes

Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass

Intra-hepatocellular lipid content (IHCL) will be compared between groups at 1 month following Roux-en-Y gastric bypass

Time frame: at 1-month following Roux-en-Y gastric bypass

Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass

Intra-hepatocellular lipid content (IHCL) will be compared between groups at 6 months following Roux-en-Y gastric bypass

Time frame: at 6 months following Roux-en-Y gastric bypass

Complexity of Surgery

Complexity of surgery will be assessed by the surgeon at the time of surgery (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group) The complexity of the surgery was assessed through a score on a complexity scale based on questionnaires previously published by Anders Thorell"s and David Edholm"s groups (Edholm et al., 2011, Van Nieuwenhove et al., 2011). The scores (1-5) for 7 variables: exposure, bleeding, difficulty in dissection, difficulty in reconstruction, surgical judgment, technical demand and psychological stress were combined into a complexity of surgery score with a minimum of 7 (very little complexity) and a maximum of 35 (very high complexity).

Time frame: at the time of surgery

Operative Time

The operative time will be recorded at the time of surgery by the operating surgeon (either after 2 weeks for the Control group and 2-week LCD group or after 6 weeks for the 6-week LCD group)

Data from ClinicalTrials.gov

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