ObesityBALONCT02418728
The Role of Atrial Natriuretic Peptide in the Lipolytic Process: Effect of Obesity and Exercise
An observational study of Obesity, run by Hasselt University at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 35 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- subcutaneous adipose tissue microdialysis under local beta/alpha blockade
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2014to Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: subjects with obesity
Who may be able to join
- 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
Who cannot join
- Regular glucose lowering medication or beta blockade medication
- Presence of chronical diseases
- Orthopedic or neurological problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- subcutaneous adipose tissue microdialysis under local beta/alpha blockade
- Keywords
- obesity, adipose tissue lipolysis, lipolysis, microdialysis, atrial natriuretic peptide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous adipose tissue microdialysis under local beta/alpha blockadeOther
adipose tissue lipolysis under local beta/alpha blockade in abdominal subcutaneous adipose tissue, using microdialysis
| Study group | Role | What they receive |
|---|---|---|
| persons with obesity | Not described Receives: Other: subcutaneous adipose tissue microdialysis under local beta/alpha blockade | |
| lean persons | Not described Receives: Other: subcutaneous adipose tissue microdialysis under local beta/alpha blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous adipose tissue microdialysis
abdominal subcutaneous adipose tissue microdialysis during rest and exercise; basal + under local alpha- and beta-blockade.
Measured: week 1
Atrial natriuretic peptide (ANP) Response
measurement systemic ANP response (venous blood sampling)
Measured: week 1
Secondary outcomes (5)
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)
Measured: screening
Echocardiography
heart function by means of standard echocardiography
Measured: Day 1
Maximal oxygen uptake (ml/O2/kg/min)
measured using indirect calorimetry and an incremental bicycle protocol
Measured: Day 1
Anthropometry
body composition, measured using dual x-ray absorptiometry, height, weight, waist and hip circumference
Measured: screening
Abdominal subcutaneous adipose tissue biopsy
biochemical, proteomics and morphological analyses
Measured: week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2015 (estimated)
- Study startAug 2014
- Primary completionAug 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Jessa Hospital, Maastricht University
- Responsible party
- Principal investigator, Dominique Hansen, Hasselt University
- Investigators
- Ellen Blaak, prof. dr., Principal investigator, Maastricht UniversityKenneth Verboven, drs, Study chair, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02418728
- Sponsor's protocol ID
- CME2014 /450
- Acronym
- BALO
- Status last verified
- Nov 2016
- First submitted
- 17 Mar 2015
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Contribution of Atrial Natriuretic Peptide in Lipid Mobilization of Subjects With Obesity, Both During Rest and Exercise
- ClinicalTrials.gov ID
- NCT02418728
- Acronym / sponsor ID
- BALO / CME2014 /450
- Conditions
- Obesity
- Keywords
- obesity, adipose tissue lipolysis, lipolysis, microdialysis, atrial natriuretic peptide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Jessa Hospital, Maastricht University
- Study start
- Aug 2014
- Primary completion
- Aug 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 16 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| persons with obesity | – | Other: subcutaneous adipose tissue microdialysis under local beta/alpha blockade |
| lean persons | – | Other: subcutaneous adipose tissue microdialysis under local beta/alpha blockade |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- subjects with obesity
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Regular glucose lowering medication or beta blockade medication
- Presence of chronical diseases
- Orthopedic or neurological problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subcutaneous adipose tissue microdialysis under local beta/alpha blockadeadipose tissue lipolysis under local beta/alpha blockade in abdominal subcutaneous adipose tissue, using microdialysis | Other | lean persons, persons with obesity |
Primary outcome
Subcutaneous adipose tissue microdialysis
Time frame: week 1
abdominal subcutaneous adipose tissue microdialysis during rest and exercise; basal + under local alpha- and beta-blockade.
Atrial natriuretic peptide (ANP) Response
Time frame: week 1
measurement systemic ANP response (venous blood sampling)
5 secondary outcomes
Central insulin sensitivity
Time frame: screening
Echocardiography
Time frame: Day 1
Maximal oxygen uptake (ml/O2/kg/min)
Time frame: Day 1
Anthropometry
Time frame: screening
Abdominal subcutaneous adipose tissue biopsy
Time frame: week 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ellen Blaak, prof. dr. principal investigator
Maastricht University
Kenneth Verboven, drs study chair
Hasselt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous adipose tissue microdialysis (time frame: week 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2016.