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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02418728
Other study ID # CME2014 /450
Secondary ID
Status Completed
Phase N/A
First received March 17, 2015
Last updated November 17, 2016
Start date August 2014
Est. completion date November 2016

Study information

Verified date November 2016
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
subcutaneous adipose tissue microdialysis under local beta/alpha blockade
adipose tissue lipolysis under local beta/alpha blockade in abdominal subcutaneous adipose tissue, using microdialysis

Locations

Country Name City State
Belgium Hasselt University Diepenbeek

Sponsors (3)

Lead Sponsor Collaborator
Hasselt University Jessa Hospital, Maastricht University

Country where clinical trial is conducted

Belgium, 

Outcome

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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