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
Protocol serial number	1
Sponsor	University Maastricht (UM) (Netherlands)
Funders	Hartcentrum Hasselt vzw (Netherlands), University Maastricht (UM) (Netherlands)

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

Department of Human Movement Sciences
Maastricht University Medical Centre
Maastricht
6200 MD
Netherlands

Study information

Primary study design	Observational
Study design	Observational cross-sectional study
Secondary study design	Cross-section survey
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/01/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes