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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Obesity

Keywords

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Liver volume Gastric bypass Magnetic resonance imaging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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DEdholm

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David Edholm, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery

Locations

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Department of surgery, Akademiska sjukhuset

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Facility Contacts

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David Edholm, Dr

Role: primary

Other Identifiers

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MR-LCD2

Identifier Type: -

Identifier Source: org_study_id