PolymorphismNCT01708083
Polymorphids an mRNA Expression in Obese Genes
An observational study of Polymorphism and mRNA Expression, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP). Are there any difference in polymorphids and/or mRNA expression in genes significant for developing obesity, between normal weight and obese… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Polymorphism, mRNA Expression
- How many people
- 50 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2010to Feb 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tree groups; group I: diabetes type II with BMI>35 Group II: no diabetes BMI>35 Group III: no diabetes BMI 18-27
Who may be able to join
- age 18 years or older
- laparoscopic surgery (Gastric by-pass, cholecystectomy, antireflux surgery)
- Normal weight without type 2 diabetes BMI 18-25
- Obese without type 2 diabetes BMI>35
- Obese with type 2 diabetes BMI>35
Who cannot join
- under 18 years
- open surgery
- pregnancy
- BMI >27-<35
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Ersta hospital
Stockholm, Stockholm County Council, 116 91
Karolinska Institutet, CMM
Stockholm, 171 76
About this study
Official title: Polymorphids and mRNA Expression in Genes, Significant for Developing Obesity and Typ II Diabetes in Different Types/Localisations of Fat Tissue
Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).
Are there any difference in polymorphids and/or mRNA expression in genes significant for developing obesity, between normal weight and obese individuals, with or without diabetes typ 2 .
Are there any difference in polymorphids and/or mRNA expression in different types of fat tissue
- Conditions
- Polymorphism, mRNA Expression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 Diabetes and BMI>35 | Patients with type 2 diabetes and body mass index 35 or more. | |
| BMI>35 | Patients undergoing surgery, gastric bypass or cholecystectomy, without diabetes type 2 and body mass index 35 or more | |
| BMI 18-27 | Patients undergoing surgery, cholecystectomy or reflux, without type 2 diabetes and body mass index between 18-27 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity
fat biopsy taken from abdomen, omenta and thigh at surgery
Measured: approximatly 30 minutes after start of operation
Difference in polymorphids and/or mRNA expression in different types of fat tissue in patients with normal weight or obesity with or without diabetes type 2
fat biopsy; abdomen, omenta and thigh taken at surgery
Measured: approximatly 30 minutes after start of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2012 (estimated)
- Study startJan 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymorphismStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Thorell, Karolinska Institutet
- Investigators
- Anders Thorell, Ass. prof., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01708083
- Sponsor's protocol ID
- 2009/1629-31/3
- Status last verified
- Aug 2013
- First submitted
- 9 Oct 2012
- Last updated
- 22 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphids and mRNA Expression in Genes, Significant for Developing Obesity and Typ II Diabetes in Different Types/Localisations of Fat Tissue
- ClinicalTrials.gov ID
- NCT01708083
- Acronym / sponsor ID
- 2009/1629-31/3
- Conditions
- Polymorphism, mRNA Expression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 16 Oct 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.
Fat tissue from omenta, thigh and abdomen taken under anesthesia on subjects undergoing laparoscopic surgery, cholecystectomy, reflux surgery or gastric by-pass (GBP).
Are there any difference in polymorphids and/or mRNA expression in genes significant for developing obesity, between normal weight and obese individuals, with or without diabetes typ 2 .
Are there any difference in polymorphids and/or mRNA expression in different types of fat tissue
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 2 Diabetes and BMI>35 | – | –Patients with type 2 diabetes and body mass index 35 or more. |
| BMI>35 | – | –Patients undergoing surgery, gastric bypass or cholecystectomy, without diabetes type 2 and body mass index 35 or more |
| BMI 18-27 | – | –Patients undergoing surgery, cholecystectomy or reflux, without type 2 diabetes and body mass index between 18-27 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tree groups; group I: diabetes type II with BMI>35 Group II: no diabetes BMI>35 Group III: no diabetes BMI 18-27
Key inclusion criteria (5 listed)
- age 18 years or older
- laparoscopic surgery (Gastric by-pass, cholecystectomy, antireflux surgery)
- Normal weight without type 2 diabetes BMI 18-25
- Obese without type 2 diabetes BMI>35
- Obese with type 2 diabetes BMI>35
Key exclusion criteria (4 listed)
- under 18 years
- open surgery
- pregnancy
- BMI >27-<35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity
Time frame: approximatly 30 minutes after start of operation
fat biopsy taken from abdomen, omenta and thigh at surgery
Difference in polymorphids and/or mRNA expression in different types of fat tissue in patients with normal weight or obesity with or without diabetes type 2
Time frame: approximatly 30 minutes after start of operation
fat biopsy; abdomen, omenta and thigh taken at surgery
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 22 Aug 2013.
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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.
Anders Thorell, Ass. prof. principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymorphism and mRNA Expression, run by Karolinska Institutet at 2 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 5 inclusion and 4 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 22 Aug 2013. 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 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?
Differences in polymorphids and/or mRNA expression in genes, significant for developing obesity and type 2 diabetes, between patients with normal weight and obesity (time frame: approximatly 30 minutes after start of operation). The study lists 2 primary outcomes in all. 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 22 Aug 2013.