Obesity Clinical Trial
— BALOOfficial title:
The Contribution of Atrial Natriuretic Peptide in Lipid Mobilization of Subjects With Obesity, Both During Rest and Exercise
| Verified date | November 2016 |
| Source | Hasselt University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 30 |
| Est. completion date | November 2016 |
| Est. primary completion date | August 2016 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 35 Years to 60 Years |
| Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Hasselt University | Diepenbeek |
| Lead Sponsor | Collaborator |
|---|---|
| Hasselt University | Jessa Hospital, Maastricht University |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Subcutaneous adipose tissue microdialysis | abdominal subcutaneous adipose tissue microdialysis during rest and exercise; basal + under local alpha- and beta-blockade. | week 1 | No |
| Primary | Atrial natriuretic peptide (ANP) Response | measurement systemic ANP response (venous blood sampling) | week 1 | No |
| Secondary | Central insulin sensitivity | Fasting serum insulin, homeostasis model assessment insulin resistance and measures of central insulin sensitivity derived from an oral glucose tolerance test (75g) | screening | No |
| Secondary | Echocardiography | heart function by means of standard echocardiography | Day 1 | No |
| Secondary | Maximal oxygen uptake (ml/O2/kg/min) | measured using indirect calorimetry and an incremental bicycle protocol | Day 1 | No |
| Secondary | Anthropometry | body composition, measured using dual x-ray absorptiometry, height, weight, waist and hip circumference | screening | No |
| Secondary | Abdominal subcutaneous adipose tissue biopsy | biochemical, proteomics and morphological analyses | week 1 | No |
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