Plain English Summary
Background and study aims
Obesity is a term used to describe somebody who is very overweight, with a lot of body fat. It's a common problem, estimated to affect around one in every four adults and around one in every five children aged 10 to 11 in the UK. People who are obese are at risk of a number of serious and potentially life-threatening conditions, such as cardiovascular disease, particularly if the disease is diagnosed at a late stage. Biomarkers (biological markers) are molecules that come from cells which can be found circulating in a person’s blood. Scientists can use these biomarkers as a way of detecting changes in a person’s body at the very earliest stages of disease. The aim of this study is to examine biomarkers found in specific blood cells called peripheral blood mononuclear cells (PBMCs). PBMCs of obese patients will be compared with those found in healthy patients to see if there are any differences that might indicate signs of early disease. This study will also compare the genes of PBMCs to see whether they might be useful for early diagnosis and treatment of obesity-related disturbances in a person’s metabolism.
Who can participate?
Men of either healthy weight or diagnosed obese.
What does the study involve?
Participants are divided into groups according to their body mass index (BMI) calculation. All participants are asked to give a blood sample which is then tested for various biomarkers associated with health and disease.
What are the possible benefits and risks of participating?
The results of this study could potentially be used as a way to diagnose and manage obesity. Participants will be asked to provide a blood sample and may experience minor discomfort from this.
Where is the study run from?
Kyungpook National University (South Korea)
When is the study starting and how long is it expected to run for?
May 2012 to April 2013
Who is funding the study?
1. SRC Program (South Korea)
2. Fundamental Technology Program (South Korea)
Who is the main contact?
Dr UJ Jung
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Differences in metabolic biomarkers in the blood and gene expression profiles of peripheral blood mononuclear cells among normal weight, mildly obese, and moderately obese subjects
Acronym
Study hypothesis
This study aims to establish metabolic and molecular differences among normal weight (BMI, 18.5~23 kg/m2), mildly obese (BMI, 25~27.5 kg/m2), and moderately obese (BMI, 27.5~30 kg/m2) Korean adult men. Levels of lipids, apolipoproteins, adipocytokines and markers of insulin resistance, oxidative stress, and liver damage in the plasma or erythrocytes will be tested alongside the gene expression profiles of peripheral blood mononuclear cells (PBMCs) using microarray analysis.
Ethics approval
Kyungpook National University Human Research Committee. ref: 2012-2.
Study design
Cross sectional study
Primary study design
Observational
Secondary study design
Cross sectional study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Blood biomarkers of people classified as normal weight, mildly obese and moderately obese according to body mass index (BMI) calculation.
Intervention
Participants are divided into groups according to their BMI: (1) mildly obese subjects (BMI between ≥25 and <27.5 kg/m2; n = 14), (2) moderately obese subjects (BMI between ≥27.5 and <30 kg/m2; n = 12) and (3) control group normal weight range (BMI between ≥18.5 and <23 kg/m2). All participants provide blood samples for screening.
Intervention type
Other
Phase
Drug names
Primary outcome measure
1. Leptin, lipids (LDL- and HDL-cholesterol), apolipoprotein B levels and adiponectin
2. Circulating levels of inflammatory cytokines and markers of insulin resistance, oxidative stress, and liver damage.
Secondary outcome measures
1. PBMC transcriptome data
2. Signaling pathways: oxidative phosphorylation; triglyceride synthesis; carbohydrate metabolism; insulin, mTOR, FOXO, RAP1, RAS, and TGF-β signaling; and ECM–receptor interaction.
Overall trial start date
01/05/2012
Overall trial end date
30/04/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Participants classed as obese, having a BMI of 25~30 kg/m2 and a normal medical history
2. Healthy participants having a BMI 18.5~23 kg/m2
Participant type
Mixed
Age group
Adult
Gender
Male
Target number of participants
37
Participant exclusion criteria
1. History of cancer or cardiac, renal, hepatic, or infectious disease.
2. Current treatment with insulin
3. Current use of drugs for controlling blood glucose, blood lipids and body weight.
4. History of gastrointestinal surgery
5. Consumption of functional foods or medications that may affect the results of this study
Recruitment start date
01/06/2012
Recruitment end date
01/07/2012
Locations
Countries of recruitment
Korea, South
Trial participating centre
Center for Food and Nutritional Genomics Research
Kyungpook National University, 1370 San-Kyuk Dong, Puk-Ku
Daegu
702-701
Korea, South
Funders
Funder type
Research organisation
Funder name
SRC program (grant number 2015R1A5A6001906)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Fundamental Technology Program (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration.
Intention to publish date
31/12/2016
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list