"Can Soluble-CD163 Discriminate Between Healthy and Unhealthy Obese Individuals?" (sCD163)

This study is currently recruiting participants.
Verified March 2013 by University of Aarhus
Sponsor:
Collaborators:
Novo Nordisk A/S
The Danish Medical Research Council
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01463449
First received: October 26, 2011
Last updated: March 15, 2013
Last verified: March 2013
  Purpose

CD163 is a membrane bound receptor primary expressed in monocytes and macrophages. A soluble variant of CD163 (sCD163) is present in plasma and is elevated in pathological condition activating the monocyte-macrophage system. Recently sCD163 is associated with various inflammatory conditions, ex. adipose tissue inflammation and very recently to be a rather strong predictor of the development of type 2-diabetes. Only a subset of obese individuals develops insulin resistance, type 2-diabetes and related diseases. These healthy obese subjects are characterized of less adipose tissue inflammation and less insulin resistance as compared to unhealthy obese individuals. Consequently it would be of great importance to develop markers that could discriminate between healthy and unhealthy obese subjects. Aim: To investigate whether macrophage CD163 is involved in adipose tissue inflammation in obesity and thereby to the metabolic complications of metabolic syndrome. To investigate how sCD163 is regulated by metabolic factors such as obesity, fat distribution, weight loss and diet. Methods: Intervention study. 45 morbidly obese subject approved to gastric by-pass. Blood samples, MR-spectroscopy, DXA, weight control and fat biopsy are taken before and 12 month after surgery. Correlations studies: to investigate the influence of diet and weight loss on CD163 and sCD163. Perspective: To study the role of macrophages infiltration and activation for adipose tissue inflammation and to determine whether the macrophage marker, s-CD163, together with other markers will be able better to identify obese individuals who are at increased risk for developing complications such as diabetes


Condition Intervention
Obesity
Insulin Resistance
Type 2-diabetes
Inflammation
Procedure: gastric bypass

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: "Influence of Obesity, Weight Loss, and Diet on Low Grade Inflammation With Particular Focus on the Macrophage Marker, Soluble-CD163 - a New Predictor of Diabetes.Can s-CD163 Discriminate Between Healthy and Unhealthy Obese Individuals?"

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Low grade inflammation in adipose tissue after weight loss induced by gastric bypass [ Time Frame: Primary endpoint after 12 months. ] [ Designated as safety issue: No ]
    sCD163 measured by enzyme-linked immunosorbent assay (ELISA). And CD163 gene expression measured by Real Time PCR (RT-PCR).


Secondary Outcome Measures:
  • Quantity of fat in the liver [ Time Frame: 12 months. ] [ Designated as safety issue: No ]
    The quantity of fat in the liver at baseline and again 12 months after surgery. Assessed by MR spectroscopy.


Biospecimen Retention:   Samples With DNA

Blood, adipose tissue


Estimated Enrollment: 45
Study Start Date: November 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Obese
Obese subjects half with type 2-diabetes. Before and after gastric bypass. Expected reduction in weight 25 %. We expect a reduction in low grade inflammation in adipose tissue after weight loss.
Procedure: gastric bypass
Low grade inflammation in adipose tissue before and after gastric bypass
Other Name: Soluble-CD163

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The cohorts will be selected from the department of Endokrinology at Aarhus University Hospital.

Criteria

Inclusion Criteria:

  • Male/Female
  • Legally competent (Habil)
  • Age 30-60
  • Approved to gastric bypass, according to current criteria in Denmark
  • Written consent
  • Investigators verification of the suitability

Exclusion Criteria:

  • Heart, liver or kidney disease
  • Treatment with cortisol
  • MR-contraindications
  • Abuse/addiction
  • Malignancy
  • Weight more than 145 kg because of problems with DXA and MRI
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01463449

Contacts
Contact: Karen Fjeldborg, Dr 0045+28729872 fjeldkaren@yahoo.dk

Locations
Denmark
Department of Endocrinology, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Karen Fjeldborg, Dr    0045+28729872    fjeldkaren@yahoo.dk   
Principal Investigator: Bjørn Richelsen, Professor         
Department of Endocrinology, Aarhus University Hospital Recruiting
Aarhus, C, Denmark, 8000
Contact: Karen Fjeldborg, Dr.    0045+28729872    fjeldkaren@yahoo.dk   
Sponsors and Collaborators
University of Aarhus
Novo Nordisk A/S
The Danish Medical Research Council
Investigators
Study Director: Bjørn Richelsen, Prof. Dr.Med Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01463449     History of Changes
Other Study ID Numbers: 17913
Study First Received: October 26, 2011
Last Updated: March 15, 2013
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Obesity
Soluble-CD163
Macrophage
Inflammation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Inflammation
Insulin Resistance
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pathologic Processes
Hyperinsulinism
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014