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

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ClinicalTrials.gov Identifier: NCT01727245
Recruitment Status : Active, not recruiting
First Posted : November 15, 2012
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment
Obesity Non-obese Controls Other: Obese Other: Control group

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions
Study Start Date : November 2011
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Body composition [ Time Frame: two years after surgery ]
    DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery

  2. Vascular function [ Time Frame: two years after surgery ]
    Non invasive ultrasound of vascular stiffness, before and two years after surgery


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: March 2017