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

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. Identifier: NCT01463449
Recruitment Status : Completed
First Posted : November 1, 2011
Last Update Posted : August 13, 2014
Novo Nordisk A/S
The Danish Medical Research Council
Information provided by (Responsible Party):
University of Aarhus

Brief Summary:
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 or disease Intervention/treatment
Obesity Insulin Resistance Type 2-diabetes Inflammation Procedure: gastric bypass

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 31 participants
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?"
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. Low grade inflammation in adipose tissue after weight loss induced by gastric bypass [ Time Frame: Primary endpoint after 12 months. ]
    sCD163 measured by enzyme-linked immunosorbent assay (ELISA). And CD163 gene expression measured by Real Time PCR (RT-PCR).

Secondary Outcome Measures :
  1. Quantity of fat in the liver [ Time Frame: 12 months. ]
    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

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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.

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

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 identifier (NCT number): NCT01463449

Department of Endocrinology, Aarhus University Hospital
Aarhus, C, Denmark, 8000
Department of Endocrinology, Aarhus University Hospital
Aarhus, Denmark, 8000
Sponsors and Collaborators
University of Aarhus
Novo Nordisk A/S
The Danish Medical Research Council
Study Director: Bjørn Richelsen, Prof. Dr.Med Aarhus University Hospital

Responsible Party: University of Aarhus Identifier: NCT01463449     History of Changes
Other Study ID Numbers: 17913
First Posted: November 1, 2011    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014

Keywords provided by University of Aarhus:

Additional relevant MeSH terms:
Insulin Resistance
Nutrition Disorders
Body Weight
Signs and Symptoms
Pathologic Processes
Glucose Metabolism Disorders
Metabolic Diseases