NCT02418728

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 16, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 18, 2016

Status Verified

November 1, 2016

Enrollment Period

2 years

First QC Date

March 17, 2015

Last Update Submit

November 17, 2016

Conditions

Keywords

obesityadipose tissue lipolysislipolysismicrodialysisatrial natriuretic peptide

Outcome Measures

Primary Outcomes (2)

  • Subcutaneous adipose tissue microdialysis

    abdominal subcutaneous adipose tissue microdialysis during rest and exercise; basal + under local alpha- and beta-blockade.

    week 1

  • Atrial natriuretic peptide (ANP) Response

    measurement systemic ANP response (venous blood sampling)

    week 1

Secondary Outcomes (5)

  • Central insulin sensitivity

    screening

  • Echocardiography

    Day 1

  • Maximal oxygen uptake (ml/O2/kg/min)

    Day 1

  • Anthropometry

    screening

  • Abdominal subcutaneous adipose tissue biopsy

    week 1

Study Arms (2)

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

Interventions

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

lean personspersons with obesity

Eligibility Criteria

Age35 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

subjects with obesity

You may qualify if:

  • 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

You may not qualify if:

  • Regular glucose lowering medication or beta blockade medication
  • Presence of chronical diseases
  • Orthopedic or neurological problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasselt University

Diepenbeek, 3590, Belgium

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ellen Blaak, prof. dr.

    Maastricht University

    PRINCIPAL INVESTIGATOR
  • Kenneth Verboven, drs

    Hasselt University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof. dr.

Study Record Dates

First Submitted

March 17, 2015

First Posted

April 16, 2015

Study Start

August 1, 2014

Primary Completion

August 1, 2016

Study Completion

November 1, 2016

Last Updated

November 18, 2016

Record last verified: 2016-11

Locations