Are the blood plasma adipokine and inflammatory marker concentrations different between obese and non-obese type 2 diabetes patients?
| ISRCTN | ISRCTN97519965 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97519965 |
| Secondary identifying numbers | 1 |
- Submission date
- 04/06/2009
- Registration date
- 24/07/2009
- Last edited
- 24/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Luc van Loon
Scientific
Scientific
Department of Human Movement Sciences
Maastricht University Medical Centre
Maastricht
6200 MD
Netherlands
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross-section survey |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Plasma adipokine and inflammatory marker concentrations in obese and non-obese type 2 diabetes patients: an observational cross-sectional study |
| Study acronym | LIRO |
| Study objectives | We hypothesise that altered plasma adipokine, inflammatory factor, and/or free fatty acid (FFA) levels are related to the obese state only and, as such, are not prevalent in non-obese type 2 diabetes patients. |
| Ethics approval(s) | Local medical ethical committee of the Virga Jesse Hospital, Hasselt, Belgium approved on the 25th November 2004 (ref: 04.37/cardio04.041) |
| Health condition(s) or problem(s) studied | Type 2 diabetes |
| Intervention | Overall, groups were matched for age and habitual physical activity (estimated by questionnaire). Additionally, non-obese type 2 diabetes patients and normoglycemic controls were matched for body mass index. Non-obese and obese type 2 diabetes patients were matched for basal fasting glucose concentrations. Fasting blood samples were collected to compare glycosylated hemoglobin (HbA1c) content, blood lipid profile, insulin, adiponectin, resistin, leptin, interleukin-6, high-sensitivity C-reactive protein, tumour necrosis factor alpha, and free fatty acid concentrations between groups. Moreover, Homeostatic Model Assessment (HOMA) index, fat free mass and whole-body oxygen uptake and workload capacity were compared between groups. All measurements were undertaken at similar time during the day (between 8.00 and 12.00 AM). |
| Intervention type | Other |
| Primary outcome measure | Fasting blood samples are collected to compare the following between groups: 1. Adiponectin 2. Resistin 3. Leptin 4. Interleukin-6 5. High-sensitivity C-reactive protein 6. Tumour necrosis factor alpha 7. Free fatty acid concentrations Subjects arrived at the hospital by car or public transportation and reported at the laboratory at 08.00 AM after an overnight fast. After 20 minutes of rest a venous blood sample was collected. |
| Secondary outcome measures | Fasting blood samples are collected to compare the following between groups: 1. Glycosylated haemoglobin (HbA1c) content 2. Blood lipid profile 3. Insulin level 4. Homeostatic Model Assessment (HOMA) index 5. Fat-free mass 6. Whole-body oxygen uptake 7. Workload capacity Subjects arrived at the hospital by car or public transportation and reported at the laboratory at 08.00 AM after an overnight fast. After 20 minutes of rest a venous blood sample was collected. |
| Overall study start date | 01/01/2008 |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 60 |
| Key inclusion criteria | A total of 60 Caucasian males (aged between 40 and 75 years) are selected to participate in this study: 20 non-obese (body mass index [BMI] less than 30 kg/m^2) and 20 obese (BMI greater than 35 kg/m^2) type 2 diabetes patients, and 20 healthy, non-obese subjects (BMI less than 30 kg/m^2). Type 2 diabetes patients are diagnosed for at least 12 months prior to investigation and are all treated with oral blood glucose lowering medication. All subjects are sedentary and do not participate in any regular exercise program and/or caloric intake restriction intervention for at least 5 years. |
| Key exclusion criteria | 1. Type 1 diabetes patients 2. Females 3. Non-adult patients 4. Deregulated diabetes |
| Date of first enrolment | 01/01/2008 |
| Date of final enrolment | 01/01/2009 |
Locations
Countries of recruitment
- Belgium
- Netherlands
Study participating centre
Department of Human Movement Sciences
Maastricht
6200 MD
Netherlands
6200 MD
Netherlands
Sponsor information
University Maastricht (UM) (Netherlands)
University/education
University/education
Postbus 616
Maastricht
6200 MD
Netherlands
| Website | http://www.unimaas.nl |
|---|---|
"ROR" |
https://ror.org/02jz4aj89 |
Funders
Funder type
Research organisation
Hartcentrum Hasselt vzw (Netherlands)
No information available
University Maastricht (UM) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
