NCT01842425

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 29, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

3.2 years

First QC Date

April 24, 2013

Last Update Submit

April 29, 2013

Conditions

Obesity

Keywords

Liver volumeGastric bypassMagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • Liver volume

    From baseline to after four weeks

Secondary Outcomes (2)

  • Composition of body fat in subcutaneous and omental fat

    At surgery

  • Changes in body composition

    Baseline to 4 weeks

Eligibility Criteria

Age20 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Morbidly obese females awaiting laparoscopic gastric bypass surgery

You may qualify if:

  • Awaiting laparoscopic gastric bypass
  • Residing near Uppsala

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of surgery, Akademiska sjukhuset

Uppsala, S-75185, Sweden

RECRUITING

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

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • David Edholm, MD

    Department of Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 24, 2013

First Posted

April 29, 2013

Study Start

October 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

SE(1)