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

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ClinicalTrials.gov Identifier: NCT01842425
Recruitment Status : Unknown
Verified April 2013 by DEdholm, Uppsala University.
Recruitment status was:  Recruiting
First Posted : April 29, 2013
Last Update Posted : April 30, 2013
Sponsor:
Information provided by (Responsible Party):
DEdholm, 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

Condition or disease
Obesity

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Changes in Body- and Liver-composition During Low Calorie Diet in Morbidly Obese
Study Start Date : October 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2015



Primary Outcome Measures :
  1. Liver volume [ Time Frame: From baseline to after four weeks ]

Secondary Outcome Measures :
  1. Composition of body fat in subcutaneous and omental fat [ Time Frame: At surgery ]
  2. Changes in body composition [ Time Frame: Baseline to 4 weeks ]

Biospecimen Retention:   Samples With DNA
Two serum samples from each patient at each examination. Biopsies of subcutananeous fat and visceral fat, approximately 1 mililiter each, taken during laparoscopic gastric bypass surgery


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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Morbidly obese females awaiting laparoscopic gastric bypass surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01842425


Locations
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Sweden
Department of surgery, Akademiska sjukhuset Recruiting
Uppsala, Sweden, S-75185
Contact: David Edholm, Dr    0046 733127764    dedholm@gmail.com   
Principal Investigator: David Edholm, Dr         
Sponsors and Collaborators
Uppsala University
Investigators
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Principal Investigator: David Edholm, MD Department of Surgery

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Responsible Party: DEdholm, MD, Uppsala University
ClinicalTrials.gov Identifier: NCT01842425     History of Changes
Other Study ID Numbers: MR-LCD2
First Posted: April 29, 2013    Key Record Dates
Last Update Posted: April 30, 2013
Last Verified: April 2013
Keywords provided by DEdholm, Uppsala University:
Liver volume
Gastric bypass
Magnetic resonance imaging