ObesityNCT01736384
Can Genetic Markers Predict Weight Loss After Gastric By-pass Surgery
An observational study of Obesity, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Gastric bypass or cholecystectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 3 sitesSweden
- Study dates
- Feb 2009to Feb 2020
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obesity
Who may be able to join
- laparoscopic gastric by-pass with BMI greater than 35
Who cannot join
- unable to understand swedish
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Karolinska Institutet, Ersta Hospital
Stockholm, SE-116 91
Karolinska Institutet, Danderyds Hospital
Stockholm, SE-182 88
Karolinska University Hospital
Stockholm
About this study
Official title: Can Genetic Changes Predict Weight Loss and Outcome After Bariatric Surgery and Can it Related to Virus Infection and Function of Liver and Adipose Tissue as Well as Lipid and Protein Profiles.
There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.
- Conditions
- Obesity
- Being tested
- Gastric bypass or cholecystectomy
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypass or cholecystectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Obesity | Gastric bypass surgery and non-obese controls undergoing cholecystectomy Receives: Procedure: Gastric bypass or cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic markers
Blood samples and tissue biopsies taken at the time of surgery and at follow-up.
Measured: day of surgery and 1 and 2 years after surgery
Secondary outcomes (3)
Lipid and protein patterns in plasma and tissues
Blood samples taken and tissue biopsies taken at the time of surgery and at follow-up
Measured: day of surgery and at 1 and 2 years postoperatively
Previous viral infection
Blood samples taken before surgery
Measured: At time of surgery
Genexpression and comorbid disease
Gene expression studies in tissue biopsies and whole blood at time of surgery and follow-up
Measured: At time of bariatric surgery and 1-2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startFeb 2009
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Danderyd Hospital, Ersta Hospital, Sweden, Karolinska University Hospital
- Responsible party
- Principal investigator, Erik Näslund, Karolinska Institutet
- Investigators
- Erik Näslund, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736384
- Sponsor's protocol ID
- 2008/1010-31/3
- Status last verified
- Feb 2020
- First submitted
- 12 Nov 2012
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Genetic Changes Predict Weight Loss and Outcome After Bariatric Surgery and Can it Related to Virus Infection and Function of Liver and Adipose Tissue as Well as Lipid and Protein Profiles.
- ClinicalTrials.gov ID
- NCT01736384
- Acronym / sponsor ID
- 2008/1010-31/3
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Ersta Hospital, Sweden, Karolinska University Hospital
- Study start
- Feb 2009 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 29 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is a variability in weight loss after gastric bypass surgery for obesity despite a standardised surgical procedure. This study aims to investigate if genetic markers can predict outcome after gastric by-pass surgery in treatment of obesity. The investigators will also study if adenovirus infection can influence the outcome after surgery. In a subgroup of patients, hormonal changes after gastric by-pass surgery will be assessed. Lipid and protein patterns will be assessed in plasma and tissues. Omental and subcutaneous fat as well as liver biopsies and whole blood are stored in a biobank. The same tissues will be collected from non-obese controls undergoing gallbladder surgery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obesity | – | Procedure: Gastric bypass or cholecystectomyGastric bypass surgery and non-obese controls undergoing cholecystectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obesity
Key inclusion criteria (1 listed)
- laparoscopic gastric by-pass with BMI greater than 35
Key exclusion criteria (1 listed)
- unable to understand swedish
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 |
|---|---|---|
| Gastric bypass or cholecystectomy | Procedure or surgery | Obesity |
Primary outcome
Genetic markers
Time frame: day of surgery and 1 and 2 years after surgery
Blood samples and tissue biopsies taken at the time of surgery and at follow-up.
3 secondary outcomes
Lipid and protein patterns in plasma and tissues
Time frame: day of surgery and at 1 and 2 years postoperatively
Previous viral infection
Time frame: At time of surgery
Genexpression and comorbid disease
Time frame: At time of bariatric surgery and 1-2 years postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2020.
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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, Professor principal investigator
Karolinska Institutet
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Karolinska Institutet at 3 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 1 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 28 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Genetic markers (time frame: day of surgery and 1 and 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2020.