ObesityDEOSHNCT01785134
Effects of Different Surgical Methods to Treat Obesity
A study testing Omentectomy and Gastric bypass operation in people with Obesity and Type 2 Diabetes, run by Karolinska Institutet at 4 sites in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Obesity, Type 2 Diabetes, Insulin Sensitivity
- What is being tested?
- Omentectomy and Gastric bypass operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 4 sitesSweden
- Study dates
- May 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- -
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Södertälje Hospital
Södertälje, Stockholm County, 15286
Ersta Hospital
Stockholm, Stockholm County, 11691
Karolinska University Hospital Huddinge
Stockholm, Stockholm County, 14186
Danderyds Hospital
Stockholm, Stockholm County, 18288
About this study
Official title: Metabolic Effects of Different Surgical Methods to Treat Obesity
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.
- Conditions
- Obesity, Type 2 Diabetes, Insulin Sensitivity
- Being tested
- Omentectomy, Gastric bypass operation
- Keywords
- Obesity, Bariatric Surgery, Insulin Sensitivity
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmentectomyProcedure or surgery
Gastric bypass operationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Control | Sham comparator | Gastric bypass operation without omentectomy. Receives: Procedure: Gastric bypass operation |
| Omentectomy | Active comparator | Gastric bypass operation in conjunction with removal of greater omentum Receives: Procedure: Omentectomy; Procedure: Gastric bypass operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin Sensitivity at 2 Years
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
Measured: 2 years postoperative
Secondary outcomes (4)
Body Composition at Two Years
Measured: 2 years postoperative
Blood Pressure at 2 Years
Measured: 2 years postoperative
Body Mass Index at 2 Years
Measured: 2 years postoperative
Blood Lipids
Measured: 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startMay 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm, The Swedish Research Council
- Responsible party
- Principal investigator, Erik Näslund, Karolinska Institutet
- Investigators
- Erik Näslund, MD, PhD, Principal investigator, Karolinska InstitutetPeter Arner, MD, PhD, Study director, Karolinska InstitutetJohan Hoffstedt, MD, PhD, Study chair, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01785134
- Sponsor's protocol ID
- CT20110061
- Other IDs
- CT20110061
- Acronym
- DEOSH
- Status last verified
- Sep 2014
- First submitted
- 30 Jan 2013
- Last updated
- 2 Oct 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 33560372Andersson 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.
PubMed 24485000
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Different Surgical Methods to Treat Obesity
- ClinicalTrials.gov ID
- NCT01785134
- Acronym / sponsor ID
- DEOSH / CT20110061
- Conditions
- Obesity, Type 2 Diabetes, Insulin Sensitivity
- Keywords
- Obesity, Bariatric Surgery, Insulin Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm, The Swedish Research Council
- Study start
- May 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 7 Feb 2013 (estimated)
- Results
- Posted 2 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Sham comparator | Procedure: Gastric bypass operationGastric bypass operation without omentectomy. |
| Omentectomy | Active comparator | Procedure: Omentectomy, Procedure: Gastric bypass operationGastric bypass operation in conjunction with removal of greater omentum |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 -
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omentectomy | Procedure or surgery | Omentectomy |
| Gastric bypass operation | Procedure or surgery | Control, Omentectomy |
Primary outcome
Insulin Sensitivity at 2 Years
Time frame: 2 years postoperative
Insulin sensitivity measured by hyperinsulinemic euglycemic clamp
4 secondary outcomes
Body Composition at Two Years
Time frame: 2 years postoperative
Blood Pressure at 2 Years
Time frame: 2 years postoperative
Body Mass Index at 2 Years
Time frame: 2 years postoperative
Blood Lipids
Time frame: 2 years postoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33560372van 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.
- Derived from this study: PubMed 24485000Andersson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik Näslund, MD, PhD principal investigator
Karolinska Institutet
Peter Arner, MD, PhD study director
Karolinska Institutet
Johan Hoffstedt, MD, PhD study chair
Karolinska Institutet
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omentectomy and Gastric bypass operation in people with Obesity and Type 2 Diabetes, run by Karolinska Institutet at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin Sensitivity at 2 Years (time frame: 2 years postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01785134, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2014; AzTrials last refreshed its copy on 7 Nov 2026.