Effects of Different Surgical Methods to Treat Obesity

NCT ID: NCT01785134

Last Updated: 2014-10-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Type 2 Diabetes Insulin Sensitivity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Control

Gastric bypass operation without omentectomy.

Group Type SHAM_COMPARATOR

Gastric bypass operation

Intervention Type PROCEDURE

Omentectomy

Gastric bypass operation in conjunction with removal of greater omentum

Group Type ACTIVE_COMPARATOR

Omentectomy

Intervention Type PROCEDURE

Gastric bypass operation

Intervention Type PROCEDURE

Interventions

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Omentectomy

Intervention Type PROCEDURE

Gastric bypass operation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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 -

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Region Stockholm

OTHER_GOV

Sponsor Role collaborator

The Swedish Research Council

OTHER_GOV

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Erik Näslund

Professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Erik Näslund, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Peter Arner, MD, PhD

Role: STUDY_DIRECTOR

Karolinska Institutet

Johan Hoffstedt, MD, PhD

Role: STUDY_CHAIR

Karolinska Institutet

Locations

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Södertälje Hospital

Södertälje, Stockholm County, Sweden

Site Status

Ersta Hospital

Stockholm, Stockholm County, Sweden

Site Status

Karolinska University Hospital Huddinge

Stockholm, Stockholm County, Sweden

Site Status

Danderyds Hospital

Stockholm, Stockholm County, Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 33560372 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24485000 (View on PubMed)

Other Identifiers

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CT20110061

Identifier Type: REGISTRY

Identifier Source: secondary_id

CT20110061

Identifier Type: -

Identifier Source: org_study_id

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