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CompletedNCT01727245Updated Feb 28, 2020

NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity

An interventional study of Obese and Control group in Obesity and Non-obese Controls, sponsored by Karolinska Institutet. Completed at 3 sites in Sweden. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Karolinska Institutet · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Nov 2011, registered Nov 2012).
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Non-randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).

02

Conditions studied

  • Obesity
  • Non-obese Controls
03

In context

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,113 studies on the registry; 267 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria obese:

  • Bariatric surgery with laparoscopic gastric by-pass

Exclusion Criteria obese:

  • diabetes mellitus typ 2 with insulin treatment and/or glitazones
  • oral or parenteral steroid treatment
  • complicated psychiatric disease
  • Warfarin use

Inclusion Criteria non-obese controls:

  • BMI under 30

Exclusion Criteria non-obese controls:

  • diabetes
  • oral or parenteral steroids treatment
  • complicated psychiatric disease
  • Warfarins use
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
500 participants (actual)

Study arms

  • Other
    Obese

    Obese patients undergoing gastric by-pass surgery

    Other: Obese

  • Other
    Control group

    Cholecystectomy and anti-reflux surgery

    Other: Control group

Interventions

  • OtherObese

    gastric bypass

  • OtherControl group

    Cholecystectomy and anti-reflux surgery

06

What researchers measure

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.

    Time frame: two years after surgery

Secondary outcomes

  1. Body composition

    DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery

    Time frame: two years after surgery

  2. Vascular function

    Non invasive ultrasound of vascular stiffness, before and two years after surgery

    Time frame: two years after surgery

07

Study locations

3 sites
  • Ersta Hospital
    Stockholm, 116 91, Sweden
  • Karolinska University Hospital
    Stockholm, 141 86, Sweden
  • Danderyds Hospital
    Stockholm, 182 88, Sweden
08

References and documents

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 33863803 ↗
  • Backdahl 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01727245
Lead sponsor
Karolinska Institutet
Collaborators
Danderyd Hospital, Ersta Hospital, Sweden, Karolinska University Hospital
Responsible party
Erik Näslund (Professor, Karolinska Institutet) — Principal investigator
First posted
Nov 15, 2012
Start date
Nov 2011
Primary completion
Dec 2019
Completion
Dec 2019
Last update
Feb 28, 2020

Study contacts

Erik Näslund, Prof.
principal investigator · Karolinska Institutet

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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