N/A N=30 Randomized Basic Science

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

Morbid Obesity · Liver Fat

Bottom Line

View on ClinicalTrials.gov: NCT02144597 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2021

Primary outcome: Primary: Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet — 40.0; 67.4; 0.1 percentage of change in IHCL

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Liquid formula low-calorie diet (LCD) (Dietary_supplement); Roux-en-Y gastric bypass (RYGB) (Procedure); Control diet (Other)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Imperial College London
Primary completion: Apr 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet	40.0; 67.4; 0.1	—
SECONDARY Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass	69.8; 88.1; 83.0	—
SECONDARY Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass	69.8; 88.1; 83.0	—
SECONDARY Complexity of Surgery	12; 13; 12	—
SECONDARY Operative Time	86; 72; 72	—

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT02144597). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.