The impact of a preoperative very low calorie ketogenic diet (VLCKD) on body composition in patients undergoing bariatric surgery: an open trial

Conditions: obesitas
Morbid obesity
10003018

Registration Number: NL-OMON51676

Lead Sponsor: Maxima Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 46

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all
of the following criteria: Patients with the age of 18-65 years are included if
they are scheduled for a primary laparoscopic Roux-en-Y gastric bypass (RYGB)
because of severe obesity. The latter is classified as a body mass index (BMI)
of >=35 kg/m2 with obesity-related comorbidities, or a BMI of >=40 kg/m2 with or
without comorbidities

Exclusion Criteria

• Weighing over 150kg because this amount is a limitation by the DXA device
• Diabetes mellitus type 1
• Allergic to milk proteins
• A recent history of a heart attack (< 12 months), heart failure or cardiac
arrhythmias
• Kidney and/or liver failure (creatinine levels >1.3 mg/dl or liver enzyme
levels (AST, ALT, GGT) less than three times over the upper normal threshold
• Current infectious, sepsis or malignant disease
• Rare condition like galactosemia, phenylketonuria or porphyria
• Persistent diarrhoea
• Hypokalaemia, chronic therapies with diuretics as furosemide and
hydrochlorothiazide
• Pregnancy or plans to get pregnant in the coming months
• Patients who did not meet criteria to be eligible for bariatric surgery (BMI
<35, psychological or unstable psychiatric disorders, inadequate dietary
regimen or inadequate exercise pattern which can*t be resolved in the upcoming
6 months)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The reduction in FFM expressed in percentages in proportion to total body<br /><br>weight loss, from baseline to 2 weeks after start of the diet, as confirmed by<br /><br>multifrequency (MF) BIA and by Dual-energy X-ray Absorptiometry (DXA).</p><br>

Secondary Outcome Measures