Effects of Different Surgical Methods to Treat Obesity (DEOSH)

This study has been completed.
Sponsor:
Collaborators:
Stockholm County Council, Sweden
The Swedish Research Council
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01785134
First received: January 30, 2013
Last updated: September 28, 2014
Last verified: September 2014
Results First Received: September 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Obesity
Type 2 Diabetes
Insulin Sensitivity
Interventions: Procedure: Omentectomy
Procedure: Gastric bypass operation

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control

Gastric bypass operation without omentectomy.

Gastric bypass operation

Omentectomy

Gastric bypass operation in conjunction with removal of greater omentum

Omentectomy

Gastric bypass operation


Participant Flow:   Overall Study
    Control     Omentectomy  
STARTED     41     40  
COMPLETED     29     33  
NOT COMPLETED     12     7  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control

Gastric bypass operation without omentectomy.

Gastric bypass operation

Omentectomy

Gastric bypass operation in conjunction with removal of greater omentum

Omentectomy

Gastric bypass operation

Total Total of all reporting groups

Baseline Measures
    Control     Omentectomy     Total  
Number of Participants  
[units: participants]
  41     40     81  
Age  
[units: years]
Mean ± Standard Deviation
  41  ± 9     43  ± 9     42  ± 9  
Gender  
[units: participants]
     
Female     41     40     81  
Male     0     0     0  
Region of Enrollment  
[units: participants]
     
Sweden     41     40     81  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Insulin Sensitivity at 2 Years   [ Time Frame: 2 years postoperative ]

2.  Secondary:   Body Composition at Two Years   [ Time Frame: 2 years postoperative ]

3.  Secondary:   Blood Pressure at 2 Years   [ Time Frame: 2 years postoperative ]

4.  Secondary:   Body Mass Index at 2 Years   [ Time Frame: 2 years postoperative ]

5.  Secondary:   Blood Lipids   [ Time Frame: 2 years postoperative ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr Erik Näslund
Organization: Karolinska Institutet
phone: +46812355017
e-mail: Erik.Naslund@ki.se


No publications provided


Responsible Party: Erik Näslund, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01785134     History of Changes
Other Study ID Numbers: CT20110061, CT20110061
Study First Received: January 30, 2013
Results First Received: September 19, 2014
Last Updated: September 28, 2014
Health Authority: Sweden: Swedish Data Inspection Board
Sweden: The National Board of Health and Welfare