NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity
The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions
1 other identifier
interventional
500
1 country
3
Brief Summary
We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Nov 2011
Longer than P75 for not_applicable obesity
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 28, 2020
February 1, 2020
8.1 years
November 12, 2012
February 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
two years after surgery
Secondary Outcomes (2)
Body composition
two years after surgery
Vascular function
two years after surgery
Study Arms (2)
Obese
OTHERObese patients undergoing gastric by-pass surgery
Control group
OTHERCholecystectomy and anti-reflux surgery
Interventions
Eligibility Criteria
You may qualify if:
- Bariatric surgery with laparoscopic gastric by-pass
You may not qualify if:
- diabetes mellitus typ 2 with insulin treatment and/or glitazones
- oral or parenteral steroid treatment
- complicated psychiatric disease
- Warfarin use
- BMI under 30
- diabetes
- oral or parenteral steroids treatment
- complicated psychiatric disease
- Warfarins use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Danderyd Hospitalcollaborator
- Ersta Hospital, Swedencollaborator
- Karolinska University Hospitalcollaborator
Study Sites (3)
Ersta Hospital
Stockholm, 116 91, Sweden
Karolinska University Hospital
Stockholm, 141 86, Sweden
Danderyds Hospital
Stockholm, 182 88, Sweden
Related Publications (2)
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.
PMID: 33863803DERIVEDBackdahl 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.
PMID: 29177471DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erik Näslund, Prof.
Karolinska Institutet
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 15, 2012
Study Start
November 1, 2011
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
February 28, 2020
Record last verified: 2020-02