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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01842425

Enrollment

Registered

2013-04-29

Start date

2012-10-31

Completion date

2015-12-31

Last updated

2013-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Liver volume, Gastric bypass, Magnetic resonance imaging

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Liver volume	From baseline to after four weeks

Secondary

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

Countries

Sweden

Outcome results