- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02418728
The Role of Atrial Natriuretic Peptide in the Lipolytic Process: Effect of Obesity and Exercise (BALO)
The Contribution of Atrial Natriuretic Peptide in Lipid Mobilization of Subjects With Obesity, Both During Rest and Exercise
In the developing countries, obesity prevalence is on a dramatic rise. Obesity is related to co-morbidities and as a result, obesity significantly shortens life expectancy and lowers quality of life. To prevent this, participation in exercise or training programs is absolutely necessary, in order to generate adipose tissue mass loss. The amount of adipose tissue mass loss is, amongst others, dependent on lipolysis which is under endocrine regulation by, mainly, catecholamines, insulin and atrial natriuretic peptide. However, large variations in adipose tissue mass loss and gain are likely in obese subjects, possibly due to a decreased lipolytic effect of these hormones (as was shown for catecholamines in the subcutaneous adipose tissue of obese subjects). However, the relative contribution of atrial natriuretic peptide in the lipolytic process remains elusive, particularly in subjects with obesity, which show an increased plasma expression of atrial natriuretic peptide.
The aim of the present study is to observe the contribution of atrial natriuretic peptide in the subcutaneous adipose tissue of obese subjects. This will be tested by measurements of extracellular glycerol levels (by microdialysis) in the subcutaneous adipose tissue in situ at rest and during endurance exercise under local beta- and alpha-blockade.
Eventually, the knowledge gained from this research will contribute to the optimization of exercise programs for people with obesity.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Diepenbeek, Belgia, 3590
- Hasselt University
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Obese group: BMI > 30 kg/m², sedentary (no regular physical activity last 6 months), insulin sensitive or insulin resistant
- Lean controls: BMI > 18.5 kg/m² and < 25 kg/m², regular physical activity, insulin sensitive
Exclusion Criteria:
- Regular glucose lowering medication or beta blockade medication
- Presence of chronical diseases
- Orthopedic or neurological problems
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
persons with obesity
|
adipose tissue lipolysis under local beta/alpha blockade in abdominal subcutaneous adipose tissue, using microdialysis
|
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lean persons
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adipose tissue lipolysis under local beta/alpha blockade in abdominal subcutaneous adipose tissue, using microdialysis
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Subcutaneous adipose tissue microdialysis
Tidsramme: week 1
|
abdominal subcutaneous adipose tissue microdialysis during rest and exercise; basal + under local alpha- and beta-blockade.
|
week 1
|
|
Atrial natriuretic peptide (ANP) Response
Tidsramme: week 1
|
measurement systemic ANP response (venous blood sampling)
|
week 1
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Central insulin sensitivity
Tidsramme: screening
|
Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g)
|
screening
|
|
Echocardiography
Tidsramme: Day 1
|
heart function by means of standard echocardiography
|
Day 1
|
|
Maximal oxygen uptake (ml/O2/kg/min)
Tidsramme: Day 1
|
measured using indirect calorimetry and an incremental bicycle protocol
|
Day 1
|
|
Anthropometry
Tidsramme: screening
|
body composition, measured using dual x-ray absorptiometry, height, weight, waist and hip circumference
|
screening
|
|
Abdominal subcutaneous adipose tissue biopsy
Tidsramme: week 1
|
biochemical, proteomics and morphological analyses
|
week 1
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ellen Blaak, prof. dr., Maastricht University
- Studiestol: Kenneth Verboven, drs, Hasselt University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CME2014 /450
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
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