NCT01785134

Brief Summary

Obese patients have an increased risk for developing severe metabolic disorders. This risk can only partly be reduced by weight reduction. The investigators have in a pilot study investigated if removal of abdominal fat (visceral) in addition to weight loss has additional beneficial effects on the metabolic profile and weight loss. This study aims to further investigate if removal of abdominal fat (major omentum) leads to beneficial metabolic effects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

4 active sites

Status
completed

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

May 1, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 7, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 2, 2014

Completed
Last Updated

October 2, 2014

Status Verified

September 1, 2014

Enrollment Period

5.6 years

First QC Date

January 30, 2013

Results QC Date

September 19, 2014

Last Update Submit

September 28, 2014

Conditions

ObesityType 2 DiabetesInsulin Sensitivity

Keywords

ObesityBariatric SurgeryInsulin Sensitivity

Outcome Measures

Primary Outcomes (1)

  • Insulin Sensitivity at 2 Years

    Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

    2 years postoperative

Secondary Outcomes (4)

  • Body Composition at Two Years

    2 years postoperative

  • Blood Pressure at 2 Years

    2 years postoperative

  • Body Mass Index at 2 Years

    2 years postoperative

  • Blood Lipids

    2 years postoperative

Study Arms (2)

Control

SHAM COMPARATOR

Gastric bypass operation without omentectomy.

Procedure: Gastric bypass operation

Omentectomy

ACTIVE COMPARATOR

Gastric bypass operation in conjunction with removal of greater omentum

Procedure: OmentectomyProcedure: Gastric bypass operation

Interventions

OmentectomyPROCEDURE
Omentectomy
Gastric bypass operationPROCEDURE
ControlOmentectomy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index over 40 kg/m2
  • Body mass index over 35 kg/m2 with obesity associated co-morbidities such as type 2 diabetes and/or additional cardiovascular risk factors -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Södertälje Hospital

Södertälje, Stockholm County, 15286, Sweden

Location

Ersta Hospital

Stockholm, Stockholm County, 11691, Sweden

Location

Karolinska University Hospital Huddinge

Stockholm, Stockholm County, 14186, Sweden

Location

Danderyds Hospital

Stockholm, Stockholm County, 18288, Sweden

Location

Related Publications (2)

  • van der Kolk BW, Muniandy M, Kaminska D, Alvarez M, Ko A, Miao Z, Valsesia A, Langin D, Vaittinen M, Paakkonen M, Jokinen R, Kaye S, Heinonen S, Virtanen KA, Andersson DP, Mannisto V, Saris WH, Astrup A, Ryden M, Blaak EE, Pajukanta P, Pihlajamaki J, Pietilainen KH. Differential Mitochondrial Gene Expression in Adipose Tissue Following Weight Loss Induced by Diet or Bariatric Surgery. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1312-1324. doi: 10.1210/clinem/dgab072.

    PMID: 33560372DERIVED

  • Andersson DP, Thorell A, Lofgren P, Wiren M, Toft E, Qvisth V, Riserus U, Berglund L, Naslund E, Bringman S, Thorne A, Arner P, Hoffstedt J. Omentectomy in addition to gastric bypass surgery and influence on insulin sensitivity: a randomized double blind controlled trial. Clin Nutr. 2014 Dec;33(6):991-6. doi: 10.1016/j.clnu.2014.01.004. Epub 2014 Jan 12.

    PMID: 24485000DERIVED

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2Insulin Resistance

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System DiseasesHyperinsulinism

Results Point of Contact

Title
Dr Erik Näslund
Organization
Karolinska Institutet
Erik.Naslund@ki.se
+46812355017

Study Officials

  • Erik Näslund, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Peter Arner, MD, PhD

    Karolinska Institutet

    STUDY DIRECTOR

  • Johan Hoffstedt, MD, PhD

    Karolinska Institutet

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, MD, PhD

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 7, 2013

Study Start

May 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

October 2, 2014

Results First Posted

October 2, 2014

Record last verified: 2014-09

Locations

SE(4)