Differences in blood metabolic and molecular biomarkers among normal weight, mildly obese, and moderately obese subjects
| ISRCTN | ISRCTN16654407 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16654407 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/04/2015
- Registration date
- 07/05/2015
- Last edited
- 10/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Kyungpook National University
Department of Food Science and Nutrition
1370 San-Kyuk Dong
Puk-Ku
Daegu
702-701
Korea, South
Study information
| Study design | Cross sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet. |
| 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 |
| Study objectives | 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(s) | Kyungpook National University Human Research Committee. ref: 2012-2. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/05/2012 |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | 37 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 01/07/2012 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Daegu
702-701
Korea, South
Sponsor information
University/education
1370 San-Kyuk Dong, Puk-Ku
Daegu
702-701
Korea, South
"ROR" |
https://ror.org/040c17130 |
|---|
Funders
Funder type
Research organisation
No information available
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration. |
| IPD sharing plan |
Editorial Notes
10/03/2016: internal review.
