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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Information provided by (Responsible Party):
Erik Näslund, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01727245
First received: November 12, 2012
Last updated: February 22, 2016
Last verified: February 2016
  Purpose
We want to asses the role of adipose tissue for metabolic complications to obesity before and after weight loss (surgery).

Condition Intervention
Obesity
Non-obese Controls
Other: Obese
Other: Control group

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Insulin sensitivity, adipose tissue function and gene function [ Time Frame: two years after surgery ] [ Designated as safety issue: No ]
    Performed with hyperinsulinemic euglycemic clamp before and two years after surgery. Subcutaneous and visceral fat biopsy at the time of surgery.


Secondary Outcome Measures:
  • Body composition [ Time Frame: two years after surgery ] [ Designated as safety issue: No ]
    DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery

  • Vascular function [ Time Frame: two years after surgery ] [ Designated as safety issue: No ]
    Non invasive ultrasound of vascular stiffness, before and two years after surgery


Enrollment: 500
Study Start Date: November 2011
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Obese
Obese patients undergoing gastric by-pass surgery
Other: Obese
gastric bypass
Control group
Cholecystectomy and anti-reflux surgery
Other: Control group
Cholecystectomy and anti-reflux surgery

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01727245

Locations
Sweden
Ersta Hospital
Stockholm, Sweden, 116 91
Karolinska University Hospital
Stockholm, Sweden, 141 86
Danderyds Hospital
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Karolinska Institutet
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Investigators
Principal Investigator: Erik Näslund, Prof. Karolinska Institutet
  More Information

Responsible Party: Erik Näslund, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01727245     History of Changes
Other Study ID Numbers: 2011/1002-31/1 
Study First Received: November 12, 2012
Last Updated: February 22, 2016
Health Authority: Sweden: The National Board of Health and Welfare

ClinicalTrials.gov processed this record on July 25, 2016