Effects of Different Surgical Methods to Treat Obesity

Metabolic Effects of Different Surgical Methods to Treat Obesity

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01785134

Acronym

DEOSH

Enrollment

Registered

2013-02-07

Start date

2006-05-31

Completion date

2011-12-31

Last updated

2014-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Type 2 Diabetes, Insulin Sensitivity

Keywords

Obesity, Bariatric Surgery, Insulin Sensitivity

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.

Interventions

PROCEDUREOmentectomy

PROCEDUREGastric bypass operation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Insulin Sensitivity at 2 Years	2 years postoperative	Insulin sensitivity measured by hyperinsulinemic euglycemic clamp

Secondary

Measure	Time frame
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

Countries

Sweden

Participant flow

Participants by arm

Arm	Count
Control Gastric bypass operation without omentectomy. Gastric bypass operation	41
Omentectomy Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation	40
Total	81

Baseline characteristics

Characteristic	Control	Omentectomy	Total
Age, Continuous	41 years STANDARD_DEVIATION 9	43 years STANDARD_DEVIATION 9	42 years STANDARD_DEVIATION 9
Region of Enrollment Sweden	41 participants	40 participants	81 participants
Sex: Female, Male Female	41 Participants	40 Participants	81 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 41	0 / 40
serious Total, serious adverse events	0 / 41	0 / 40