N/A
Completed N=30
Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
Morbid Obesity · Liver Fat
Source: ClinicalTrials.gov NCT02144597 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcomePrimary: Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet — 40.0; 67.4; 0.1 percentage of change in IHCL
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.
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 Complexity of Surgery |
12; 13; 12 | — |
| SECONDARY Operative Time |
86; 72; 72 | — |
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
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. Informational only — not medical advice.