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

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ClinicalTrials.gov Identifier: NCT01727245
Recruitment Status : Completed
First Posted : November 15, 2012
Last Update Posted : February 28, 2020
Sponsor:
Collaborators:
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE November 12, 2012
First Posted Date  ICMJE November 15, 2012
Last Update Posted Date February 28, 2020
Actual Study Start Date  ICMJE November 2011
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2013)
  • Body composition [ Time Frame: two years after surgery ]
    DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery
  • Vascular function [ Time Frame: two years after surgery ]
    Non invasive ultrasound of vascular stiffness, before and two years after surgery
Original Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2012)
  • Body composition [ Time Frame: two years after surgery ]
    DEXA, Dual-energy X-ray absorptiometry, before and two years after surgery
  • Vascular function [ Time Frame: two years after surgery ]
    Non invasiv ultrasound of vascular stiffness, before and two years after surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE NEFA (Non Esterified Fatty Acid) , Adipose Factors Behind Insulin Sensitivity
Official Title  ICMJE The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions
Brief Summary We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Obesity
  • Non-obese Controls
Intervention  ICMJE
  • Other: Obese
    gastric bypass
  • Other: Control group
    Cholecystectomy and anti-reflux surgery
Study Arms  ICMJE
  • Obese
    Obese patients undergoing gastric by-pass surgery
    Intervention: Other: Obese
  • Control group
    Cholecystectomy and anti-reflux surgery
    Intervention: Other: Control group
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 12, 2012)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01727245
Other Study ID Numbers  ICMJE 2011/1002-31/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Erik Näslund, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE
  • Danderyd Hospital
  • Ersta Hospital, Sweden
  • Karolinska University Hospital
Investigators  ICMJE
Principal Investigator: Erik Näslund, Prof. Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP