ObesityNCT01727245
NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity
A study testing Obese in people with Obesity and Non-obese Controls, run by Karolinska Institutet at 3 sites in Sweden.
Trial summary
We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Non-obese Controls
- What is being tested?
- Obese
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 3 sitesSweden
- Study dates
- Nov 2011to Dec 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Bariatric surgery with laparoscopic gastric by-pass
- BMI under 30
Who cannot join
- diabetes mellitus typ 2 with insulin treatment and/or glitazones
- oral or parenteral steroid treatment
- complicated psychiatric disease
- Warfarin use
- diabetes
- oral or parenteral steroids treatment
- complicated psychiatric disease
- Warfarins use
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Ersta Hospital
Stockholm, 116 91
Karolinska University Hospital
Stockholm, 141 86
Danderyds Hospital
Stockholm, 182 88
About this study
Official title: The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions
We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).
- Conditions
- Obesity, Non-obese Controls
- Being tested
- Obese, Control group
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObeseOther
gastric bypass
Control groupOther
Cholecystectomy and anti-reflux surgery
| Study group | Role | What they receive |
|---|---|---|
| Obese | Other | Obese patients undergoing gastric by-pass surgery Receives: Other: Obese |
| Control group | Other | Cholecystectomy and anti-reflux surgery Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity, adipose tissue function and gene function
Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery.
Measured: two years after surgery
Secondary outcomes (2)
Body composition
DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery
Measured: two years after surgery
Vascular function
Non invasive ultrasound of vascular stiffness, before and two years after surgery
Measured: two years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 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, Prof., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727245
- Sponsor's protocol ID
- 2011/1002-31/1
- Status last verified
- Feb 2020
- First submitted
- 12 Nov 2012
- Last updated
- 28 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Mileti E, Kwok KHM, Andersson DP, Mathelier A, Raman A, Backdahl J, Jalkanen J, Massier L, Thorell A, Gao H, Arner P, Mejhert N, Daub CO, Ryden M. Human White Adipose Tissue Displays Selective Insulin Resistance in the Obese State. Diabetes. 2021 Jul;70(7):1486-1497. doi: 10.2337/db21-0001. Epub 2021 Apr 16.
PubMed 33863803Backdahl J, Andersson DP, Eriksson-Hogling D, Caidahl K, Thorell A, Mileti E, Daub CO, Arner P, Ryden M. Long-Term Improvement in Aortic Pulse Wave Velocity After Weight Loss Can Be Predicted by White Adipose Tissue Factors. Am J Hypertens. 2018 Mar 10;31(4):450-457. doi: 10.1093/ajh/hpx201.
PubMed 29177471
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
- The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions
- ClinicalTrials.gov ID
- NCT01727245
- Acronym / sponsor ID
- 2011/1002-31/1
- Conditions
- Obesity, Non-obese Controls
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Danderyd Hospital, Ersta Hospital, Sweden, Karolinska University Hospital
- Study start
- Nov 2011 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 15 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.
We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese | Other | Other: ObeseObese patients undergoing gastric by-pass surgery |
| Control group | Other | Other: Control groupCholecystectomy and anti-reflux surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Bariatric surgery with laparoscopic gastric by-pass
- BMI under 30
Key exclusion criteria (8 listed)
- diabetes mellitus typ 2 with insulin treatment and/or glitazones
- oral or parenteral steroid treatment
- complicated psychiatric disease
- Warfarin use
- diabetes
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 |
|---|---|---|
| Obesegastric bypass | Other | Obese |
| Control groupCholecystectomy and anti-reflux surgery | Other | Control group |
Primary outcome
Insulin sensitivity, adipose tissue function and gene function
Time frame: two years after surgery
Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery.
2 secondary outcomes
Body composition
Time frame: two years after surgery
Vascular function
Time frame: two years after 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 28 Feb 2020.
- Derived from this study: PubMed 33863803Mileti E, Kwok KHM, Andersson DP, Mathelier A, Raman A, Backdahl J, Jalkanen J, Massier L, Thorell A, Gao H, Arner P, Mejhert N, Daub CO, Ryden M. Human White Adipose Tissue Displays Selective Insulin Resistance in the Obese State. Diabetes. 2021 Jul;70(7):1486-1497. doi: 10.2337/db21-0001. Epub 2021 Apr 16.
- Derived from this study: PubMed 29177471Backdahl J, Andersson DP, Eriksson-Hogling D, Caidahl K, Thorell A, Mileti E, Daub CO, Arner P, Ryden M. Long-Term Improvement in Aortic Pulse Wave Velocity After Weight Loss Can Be Predicted by White Adipose Tissue Factors. Am J Hypertens. 2018 Mar 10;31(4):450-457. doi: 10.1093/ajh/hpx201.
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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, Prof. 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?
A study testing Obese in people with Obesity and Non-obese Controls, 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 2 inclusion and 8 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?
Insulin sensitivity, adipose tissue function and gene function (time frame: two years after surgery). 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 NCT01727245, 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 28 Feb 2020.