Changes in Body- and Liver-composition During Low Calorie Diet in Morbidly Obese

• Conditions: Obesity

• Registration Number: NCT01842425
• Lead Sponsor: Uppsala University

Brief Summary

The purpose of this study is to determine what changes occur in body- and liver-composition during four weeks of low calorie diet in morbidly obese females

Detailed Description

Preoperative weight loss prior to laparoscopic gastric bypass is desirable as this reduces liver volume and thus facilitates the visualization of the gastro-esophageal junction. Weight loss is often achieved through low-calorie diet (LCD); however the ideal duration of LCD treatment is unknown.

Morbidly obese female patients awaiting laparoscopic gastric bypass are recruited. They are, as all our patients, treated during four weeks with LCD to achieve a decrease in liver size. During this period they are examined on day 0, 3, 7, 14 and 28 after commencing LCD.

At each evaluation, body composition is assessed through bioelectric impedance analysis (BIA), liver volume and intrahepatic fat through magnetic resonance imaging. A questionnaire regarding quality of life and LCD-related symptoms is administered as well. At surgery two samples of subcutaneous fat and one sample of omental fat is taken.

We do not assign patients to different treatments, instead all are treated similarly according to our routine preoperative regimen.

Study Timeline

• Study Start: 2012-10
• Status Verified: 2013-04
• Study First Submitted: 2013-04-24
• Study First Submitted QC: 2013-04-24
• Study First Posted: 2013-04-29
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-04-30
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Awaiting laparoscopic gastric bypass
• Residing near Uppsala

Exclusion Criteria

• Weight above 140 kg
• Metal implants such as pacemaker or intracerebral clips
• Failure to understand or comply with study protocol

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Liver volume	From baseline to after four weeks

Secondary Outcome Measures

Name	Time	Method
Changes in body composition	Baseline to 4 weeks
Composition of body fat in subcutaneous and omental fat	At surgery

Trial Locations

Locations (1)

Department of surgery, Akademiska sjukhuset; 🇸🇪 Uppsala, Sweden