Clinical trial NCT02144597: Low-calorie Diet and Body Composition Prior to Roux-en-Y Gastric Bypass
Official title: The Effect of a 2-week vs. 6-week Low-calorie Diet (LCD) Followed by Roux-en-Y Gastric Bypass (RYGB) on Body Composition and Surgery Outcomes in Obese Humans: a Dietary Intervention and Magnetic Resonance Imaging Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Liver Fat
Keywords: morbid obesity
gastric bypass
bariatrics
diet
caloric restriction
liver fat
appetite
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Cambridge Weight Plan Limited
First posted: 2014-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed description: 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.

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

Primary outcomes:
measure: Change in Intra-hepatocellular Lipid Content (IHCL) Following the Pre-operative Diet
timeFrame: at 2 weeks or 6 weeks depending on group
Secondary outcomes:
measure: Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
timeFrame: at 1-month following Roux-en-Y gastric bypass
measure: Change in Intra-hepatocellular Lipid Content (IHCL) Following Roux-en-Y Gastric Bypass
timeFrame: at 6 months following Roux-en-Y gastric bypass
measure: Complexity of Surgery
timeFrame: at the time of surgery
measure: Operative Time
timeFrame: at the time of surgery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial Clinical research facility
state: Greater London
Study officials:
affiliation: Imperial College London
name: Prof Gary S Frost, RD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bottin JH, Balogun B, Thomas EL, Fitzpatrick JA, Moorthy K, Leeds AR, Bell JD, Frost GS. Changes in body composition induced by pre-operative liquid low-calorie diet in morbid obese patients undergoing Roux-en-Y gastric bypass. Obesity reviews (March 2014), 15 (suppl 2): 129-176. (T5:S24.05). doi: 10.1111/obr.12151