Effects of Different Surgical Methods to Treat Obesity (DEOSH)

Karolinska Institute

Status: Completed

Conditions: Obesity; Type 2 Diabetes; Insulin Sensitivity

Treatments: Procedure: Omentectomy; Procedure: Gastric bypass operation

Study type: Interventional

Funder types: Other

Identifiers

NCT01785134

CT20110061 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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81 participants in 2 patient groups

Control

Sham Comparator group

Description:

Gastric bypass operation without omentectomy.

Treatment:

Procedure: Gastric bypass operation

Omentectomy

Active Comparator group

Description:

Gastric bypass operation in conjunction with removal of greater omentum

Treatment:

Procedure: Gastric bypass operation

Procedure: Omentectomy