- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02598544
Endocrine Regulation of Lipolysis in Obesity and Diabetes (ERLO)
November 16, 2016 updated by: Dominique Hansen, Hasselt University
Atrial Natriuretic Peptide (ANP)-Induced Lipid Mobilization Regulation in Different Adipose Tissue Depots of Obese Subjects
Adipose tissue (AT) dysfunction is a commonly observed feature of metabolic dysfunction in obesity and diabetes.
An important characteristic when examining AT function is the capacity to break down stored lipids (i.e.
lipolysis) and its regulation.
In the present study, the aim was to investigate whether atrial natriuretic peptide-mediated lipolysis is altered in different adipose tissue depots (subcutaneous and visceral adipose tissue) of obese subjects with or without type 2 diabetes, compared to age-matched lean men.
Eventually, the knowledge gained from this research will contribute to a better understanding of the present adipose tissue dysfunction and to the optimization of exercise programs for people with obesity and diabetes.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Diepenbeek, Belgium, B-3590
- Hasselt University
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Genk, Belgium, B-3600
- Ziekenhuis Oost-Limburg
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Hasselt, Belgium, B-3500
- Jessa Ziekenhuis
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-
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Maastricht, Netherlands
- Maastricht University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Lean group: BMI < 25 kg/m², insulin sensitive (HOMA-Insuline Resistance (IR) < 2.3), age 40-65
- Obese groups: BMI > 30 kg/m², presence or absence of type 2 diabetes based on use of glucose lowering medication or HbA1c > 6.5%, age 40-65
Exclusion Criteria:
- presence of a history of heart, lung or kidney disease and/or presence of endocrine anomalies. Use of beta-blockade medication.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: lean men
|
adipose tissue (subcutaneous and visceral adipose tissue) sampling during abdominal surgery and phenotype determination
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Other: Obese men without type 2 diabetes
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adipose tissue (subcutaneous and visceral adipose tissue) sampling during abdominal surgery and phenotype determination
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Other: Obese men with type 2 diabetes
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adipose tissue (subcutaneous and visceral adipose tissue) sampling during abdominal surgery and phenotype determination
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycerol release by mature adipocytes, isolated from subcutaneous and visceral adipose tissue, upon stimulation with isoprenalin or ANP (ex vivo)
Time Frame: day 1
|
Investigation of concentration effect of ISO/ANP on lipolysis (glycerol release) by mature adipocytes isolated from adipose tissue biopsies, glycerol release is measured in the incubation medium following a 3 hour incubation period.
Measured for adipose tissue (subcutaneous and visceral adipose tissue) of both lean and obese subjects
|
day 1
|
|
ANP receptor expression profiles on mRNA and protein level in both adipose tissue depots for both lean and obese subjects.
Time Frame: day 1
|
Receptor expression determination in order to clarify the underlying mechanism responsible for possible differences in lipolytic responses.
|
day 1
|
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Adipose tissue inflammation
Time Frame: day 1
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Adipose tissue inflammation (by means of FACS analysis) and its relation to insulin sensitivity and adipose tissue function in lean, obese and obese diabetics subjects.
|
day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Body composition
Time Frame: day 1
|
Body composition (body fath percentage), measured by BIA
|
day 1
|
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BMI (kg/m²)
Time Frame: day 1
|
day 1
|
|
|
body height (m)
Time Frame: day 1
|
day 1
|
|
|
weight (kg)
Time Frame: day 1
|
day 1
|
|
|
hip circumference (cm)
Time Frame: Day 1
|
Day 1
|
|
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waist (cm)
Time Frame: Day 1
|
Day 1
|
|
|
blood glucose
Time Frame: day 1
|
day 1
|
|
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blood insuline
Time Frame: day 1
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day 1
|
|
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blood FFA
Time Frame: day 1
|
day 1
|
|
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blood triglycerides
Time Frame: day 1
|
day 1
|
|
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blood glycated hemoglobin
Time Frame: day 1
|
day 1
|
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blood ANP
Time Frame: day 1
|
fasting blood sample to determine blood glucose, insulin, FFA, , glycated hemoglobin and ANP
|
day 1
|
|
blood pressure (mmHg)
Time Frame: Day 1
|
Day 1
|
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Concomitant medication
Time Frame: Day 1
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ellen Blaak, prof. dr., Maastricht University
- Study Chair: Kenneth Verboven, drs., Hasselt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 16, 2015
First Submitted That Met QC Criteria
November 4, 2015
First Posted (Estimate)
November 6, 2015
Study Record Updates
Last Update Posted (Estimate)
November 18, 2016
Last Update Submitted That Met QC Criteria
November 16, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14.17/REVA14.02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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