Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/06/2009
Date assigned
24/07/2009
Last edited
24/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luc van Loon

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

Plasma adipokine and inflammatory marker concentrations in obese and non-obese type 2 diabetes patients: an observational cross-sectional study

Acronym

LIRO

Study hypothesis

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

Local medical ethical committee of the Virga Jesse Hospital, Hasselt, Belgium approved on the 25th November 2004 (ref: 04.37/cardio04.041)

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross-section survey

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/01/2008

Overall trial end date

01/01/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

60

Participant exclusion criteria

1. Type 1 diabetes patients
2. Females
3. Non-adult patients
4. Deregulated diabetes

Recruitment start date

01/01/2008

Recruitment end date

01/01/2009

Locations

Countries of recruitment

Belgium

Trial participating centre

Department of Human Movement Sciences
Maastricht
6200 MD
Netherlands

Sponsor information

Organisation

University Maastricht (UM) (Netherlands)

Sponsor details

Postbus 616
Maastricht
6200 MD
Netherlands

Sponsor type

University/education

Website

http://www.unimaas.nl

Funders

Funder type

Research organisation

Funder name

Hartcentrum Hasselt vzw (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Maastricht (UM) (Netherlands)

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes