Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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 Phase
Obesity Non-obese Controls Other: Obese Other: Control group Not Applicable

Layout table for study information
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
Actual Study Start Date : November 2011
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

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




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Erik Näslund, Prof. Karolinska Institutet
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Erik Näslund, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01727245    
Other Study ID Numbers: 2011/1002-31/1
First Posted: November 15, 2012    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020