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ObesityPhase 4ASGARDNCT00327912

Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Biliopancreatic Diversion (BPD)- Duodenal Switch for Superobesity

A Phase 4 study testing Laparoscopic Biliopancreatic diversion with Duodenal switch and Laparoscopic Roux-en-Y Gastric Bypass in people with Obesity and Diabetes, run by Göteborg University at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index [BMI] > 50 kg/m2). Read more about this study

Who is it for?
Ages 20 to 50 years
Conditions the study is for
Obesity, Diabetes, Hypertension
What is being tested?
Laparoscopic Biliopancreatic diversion with Duodenal switch and Laparoscopic Roux-en-Y Gastric Bypass
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesin 2 countries
Study dates
Apr 2006to Dec 2017
Phase
Phase 4
Are there results?
None posted in the registry

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 20 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • BMI 50-60 kg/m2

Who cannot join

  • Prior obesity operation
  • Prior major abdominal surgical procedure
  • Severe disabling cardiopulmonary disease
  • Malignancy
  • Oral steroid treatment
  • Condition associated with poor compliance

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Norway1 site

  • Dept of Surgery, Aker University Hospital

    Oslo, Oslo

Other trials in Norway

Sweden1 site

  • Dept of Surgery, Sahlgrenska University Hospital

    Gothenburg, Gothenburg, 41345

Other trials in Sweden

About this study

Official title: Laparoscopic Roux-en-Y Gastric Bypass vs. Laparoscopic BPD-Duodenal Switch for Superobesity (BMI > 50 kg/m2)- A Randomized Clinical Trial

The purpose of this study is to compare the outcome in a broad perspective after laparoscopic Roux-en-Y gastric bypass and laparoscopic BPD-duodenal switch in the treatment of superobesity (body mass index [BMI] > 50 kg/m2).

Read the detailed description

Surgery is the only treatment of morbid obesity that has proven to result in efficient and long lasting weight loss. There are few studies comparing different surgical techniques, especially in a randomized setting.

Superobesity (BMI > 50 kg/m2) demands an efficient surgical approach to result in satisfying weight loss. Laparoscopic techniques have been established to perform Roux-en-Y Gastric bypass and Biliopancreatic Diversion with Duodenal Switch which both are good options for treating superobesity.

This study aims to compare the outcome after surgery in a broad perspective (weight loss, metabolic normalization, gastro-intestinal side effects, eating patterns, body composition, health economics). Patients will be randomized to either surgical procedure and will be followed for five years.

Being tested
Laparoscopic Biliopancreatic diversion with Duodenal switch, Laparoscopic Roux-en-Y Gastric Bypass
Keywords
Obesity, Surgery, Gastric bypass, Biliopancreatic diversion with Duodenal switch, Laparoscopy
Medical subject headings
Obesity, Diabetes Mellitus, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic Biliopancreatic diversion with Duodenal switchProcedure or surgery

  • Laparoscopic Roux-en-Y Gastric BypassProcedure or surgery

Study groups in NCT00327912
Study groupRoleWhat they receive
1ExperimentalLaparoscopic Biliopancreatic diversion with Duodenal switch
Receives: Procedure: Laparoscopic Biliopancreatic diversion with Duodenal switch
2Active comparatorLaparoscopic Roux-en-Y Gastric Bypass
Receives: Procedure: Laparoscopic Roux-en-Y Gastric Bypass

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. BMI

    Measured: 5 y

  2. Metabolic normalization

    Measured: 5y

  3. Gastro-intestinal side effects

    Measured: 5y

Secondary outcomes (5)

  1. Health economics

    Measured: 5y

  2. Vitamin/mineral deficiencies

    Measured: 5y

  3. Body composition

    Measured: 5y

  4. Quality of life

    Measured: 5y

  5. Eating pattern

    Measured: 5y

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2006 (estimated)
  2. Study startApr 2006
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00327912
Sponsor's protocol ID
SU688-02
Acronym
ASGARD
Status last verified
Feb 2017
First submitted
18 May 2006
Last updated
2 Feb 2017
Results posted
No

Publications

  • Salte OBK, Olbers T, Risstad H, Fagerland MW, Sovik TT, Blom-Hogestol IK, Kristinsson JA, Engstrom M, Mala T. Ten-Year Outcomes Following Roux-en-Y Gastric Bypass vs Duodenal Switch for High Body Mass Index: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2414340. doi: 10.1001/jamanetworkopen.2024.14340.

    PubMed 38829616

  • Risstad H, Sovik TT, Engstrom M, Aasheim ET, Fagerland MW, Olsen MF, Kristinsson JA, le Roux CW, Bohmer T, Birkeland KI, Mala T, Olbers T. Five-year outcomes after laparoscopic gastric bypass and laparoscopic duodenal switch in patients with body mass index of 50 to 60: a randomized clinical trial. JAMA Surg. 2015 Apr;150(4):352-61. doi: 10.1001/jamasurg.2014.3579.

    PubMed 25650964

  • Sovik TT, Aasheim ET, Taha O, Engstrom M, Fagerland MW, Bjorkman S, Kristinsson J, Birkeland KI, Mala T, Olbers T. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. 2011 Sep 6;155(5):281-91. doi: 10.7326/0003-4819-155-5-201109060-00005.

    PubMed 21893621

  • Sovik TT, Taha O, Aasheim ET, Engstrom M, Kristinsson J, Bjorkman S, Schou CF, Lonroth H, Mala T, Olbers T. Randomized clinical trial of laparoscopic gastric bypass versus laparoscopic duodenal switch for superobesity. Br J Surg. 2010 Feb;97(2):160-6. doi: 10.1002/bjs.6802.

    PubMed 20035530

  • Aasheim ET, Bjorkman S, Sovik TT, Engstrom M, Hanvold SE, Mala T, Olbers T, Bohmer T. Vitamin status after bariatric surgery: a randomized study of gastric bypass and duodenal switch. Am J Clin Nutr. 2009 Jul;90(1):15-22. doi: 10.3945/ajcn.2009.27583. Epub 2009 May 13.

    PubMed 19439456

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Laparoscopic Biliopancreatic diversion with Duodenal switch and Laparoscopic Roux-en-Y Gastric Bypass in people with Obesity and Diabetes, run by Göteborg University at 2 sites in 2 countries.

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 1 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 2 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Norway, 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

BMI (time frame: 5 y). The study lists 3 primary outcomes in all. 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 NCT00327912, which also lists 5 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 Feb 2017.

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