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

February 27, 2020 updated by: Erik Näslund, Karolinska Institutet

The Role of Adipose Tissue in Atherogenic Conditions in Man - Mechanisms and Interventions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 116 91
        • Ersta Hospital
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital
      • Stockholm, Sweden, 182 88
        • Danderyds Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Obese
Obese patients undergoing gastric by-pass surgery
Other: Obese
gastric bypass
Other: Control group
Cholecystectomy and anti-reflux surgery
Other: Control group
Cholecystectomy and anti-reflux surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
two years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body composition
Time Frame: two years after surgery
DEXA (Dual-Energy X-ray absorptiometry), before and two years after surgery
two years after surgery
Vascular function
Time Frame: two years after surgery
Non invasive ultrasound of vascular stiffness, before and two years after surgery
two years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital
Danderyd Hospital
Ersta Hospital, Sweden

Investigators

  • Principal Investigator: Erik Näslund, Prof., Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

November 12, 2012

First Submitted That Met QC Criteria

November 12, 2012

First Posted (Estimate)

November 15, 2012

Study Record Updates

Last Update Posted (Actual)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 27, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2011/1002-31/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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