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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01842425
• Other study ID #: MR-LCD2
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2013
• Last updated: April 29, 2013
• Start date: October 2012
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 60 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Sweden	Department of surgery, Akademiska sjukhuset	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver volume		From baseline to after four weeks	No
Secondary	Composition of body fat in subcutaneous and omental fat		At surgery	No
Secondary	Changes in body composition		Baseline to 4 weeks	No