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NEFA, Adipose Factors Behind Insulin Sensitivity

This study is currently recruiting participants.
Verified November 2012 by Karolinska Institutet
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: NA
Last verified: November 2012
History: No changes posted
  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

Resource links provided by NLM:

U.S. FDA Resources

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 invasiv ultrasound of vascular stiffness, before and two years after surgery


Estimated Enrollment: 500
Study Start Date: November 2011
Estimated Primary Completion Date: December 2014 (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
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
  • Warfarine use

Inclusion Criteria non-obese controls:

  • BMI under 30

Exclusion Criteria non-obese controls:

  • diabetes
  • oral or parenteral steroide treatment
  • complicated psychiatric disease
  • Warfarine use
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727245

Contacts
Contact: Erik Näslund, Prof. +46 8 123 550 17 erik.naslund@ki.se
Contact: Mikael Ryden, Ass. Prof +46 8 5858 2775 mikael.ryden@ki.se

Locations
Sweden
Danderyds Hospital Recruiting
Stockholm, Sweden, 182 88
Contact: Erik Näslund, Prof.     +46 8 123550 17     erik.naslund@ki.se    
Principal Investigator: Erik Näslund, Prof.            
Ersta Hospital Recruiting
Stockholm, Sweden, 116 91
Contact: Anders Thorell, Ass. Prof.     +46 8 714 6541     anders.thorell@erstadiakoni.se    
Sub-Investigator: Anders Thorell, Ass. Prof.            
Karolinska University Hospital Recruiting
Stockholm, Sweden, 141 86
Contact: Mikael Ryden, Ass. Prof.     +46 8 5858 2775     mikael.ryden@ki.se    
Sub-Investigator: Mikael Ryden, Ass. Prof.            
Sponsors and Collaborators
Karolinska Institutet
Danderyd Hospital
Ersta Hospital, Sweden
Karolinska University Hospital
Investigators
Principal Investigator: Erik Näslund, Prof. Karolinska Institutet
  More Information

No publications provided

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: November 12, 2012
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013