"Can Soluble-CD163 Discriminate Between Healthy and Unhealthy Obese Individuals?"
sCD163
"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?"
1 other identifier
observational
31
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2011
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2011
CompletedFirst Posted
Study publicly available on registry
November 1, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedAugust 13, 2014
August 1, 2014
2.1 years
October 26, 2011
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Low grade inflammation in adipose tissue after weight loss induced by gastric bypass
sCD163 measured by enzyme-linked immunosorbent assay (ELISA). And CD163 gene expression measured by Real Time PCR (RT-PCR).
Primary endpoint after 12 months.
Secondary Outcomes (1)
Quantity of fat in the liver
12 months.
Study Arms (1)
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.
Interventions
Low grade inflammation in adipose tissue before and after gastric bypass
Eligibility Criteria
The cohorts will be selected from the department of Endokrinology at Aarhus University Hospital.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- Novo Nordisk A/Scollaborator
- The Danish Medical Research Councilcollaborator
Study Sites (2)
Department of Endocrinology, Aarhus University Hospital
Aarhus, 8000, Denmark
Department of Endocrinology, Aarhus University Hospital
Aarhus C, 8000, Denmark
Biospecimen
Blood, adipose tissue
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bjørn Richelsen, Prof. Dr.Med
Aarhus University Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2011
First Posted
November 1, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2013
Study Completion
August 1, 2014
Last Updated
August 13, 2014
Record last verified: 2014-08