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| ID | Type | Description | Link |
|---|---|---|---|
| CT20110061 | Registry Identifier | Karolinska Clinical Trial Registration |
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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
| The Swedish Research Council | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Sham Comparator | Gastric bypass operation without omentectomy. |
|
| Omentectomy | Active Comparator | Gastric bypass operation in conjunction with removal of greater omentum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omentectomy | Procedure |
| ||
| Gastric bypass operation |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity at 2 Years | Insulin sensitivity measured by hyperinsulinemic euglycemic clamp | 2 years postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition at Two Years | 2 years postoperative | |
| Blood Pressure at 2 Years | 2 years postoperative | |
| Body Mass Index at 2 Years |
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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:
-
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| Name | Affiliation | Role |
|---|---|---|
| Erik Näslund, MD, PhD | Karolinska Institutet | Principal Investigator |
| Peter Arner, MD, PhD | Karolinska Institutet | Study Director |
| Johan Hoffstedt, MD, PhD | Karolinska Institutet | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Södertälje Hospital | Södertälje | Stockholm County | 15286 | Sweden | ||
| Ersta Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33560372 | Derived | 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. | |
| 24485000 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Gastric bypass operation without omentectomy. Gastric bypass operation |
| FG001 | Omentectomy | Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Gastric bypass operation without omentectomy. Gastric bypass operation |
| BG001 | Omentectomy | Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Insulin Sensitivity at 2 Years | Insulin sensitivity measured by hyperinsulinemic euglycemic clamp | Mean | Standard Deviation | glucose/kg body weight/min | 2 years postoperative |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Gastric bypass operation without omentectomy. Gastric bypass operation |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Erik Näslund | Karolinska Institutet | +46812355017 | Erik.Naslund@ki.se |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 2 years postoperative |
| Blood Lipids | 2 years postoperative |
| Stockholm |
| Stockholm County |
| 11691 |
| Sweden |
| Karolinska University Hospital Huddinge | Stockholm | Stockholm County | 14186 | Sweden |
| Danderyds Hospital | Stockholm | Stockholm County | 18288 | Sweden |
| Derived |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Body Composition at Two Years | Mean | Standard Deviation | % body fat | 2 years postoperative |
|
|
|
| Secondary | Blood Pressure at 2 Years | Mean | Standard Deviation | mm Hg systolic | 2 years postoperative |
|
|
|
| Secondary | Body Mass Index at 2 Years | Mean | Standard Deviation | Kg/meter squared | 2 years postoperative |
|
|
|
| Secondary | Blood Lipids | Mean | Standard Deviation | P-Cholesterol mmol/L | 2 years postoperative |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Omentectomy | Gastric bypass operation in conjunction with removal of greater omentum Omentectomy Gastric bypass operation | 0 | 40 | 0 | 40 |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |