AzTrials
AzTrials

ObesityERLONCT02598544

Endocrine Regulation of Lipolysis in Obesity and Diabetes

A study testing adipose tissue sampling in people with Obesity and Diabetes, run by Hasselt University at 4 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Obesity, Diabetes
What is being tested?
adipose tissue sampling
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
4 sitesin 2 countries
Study dates
May 2013to Apr 2015
Phase
Interventional
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 40 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • presence of a history of heart, lung or kidney disease and/or presence of endocrine anomalies. Use of beta-blockade medication.

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Belgium3 sites

  • Hasselt University

    Diepenbeek, B-3590

  • Ziekenhuis Oost-Limburg

    Genk, B-3600

  • Jessa Ziekenhuis

    Hasselt, B-3500

Other trials in Belgium

Netherlands1 site

  • Maastricht University

    Maastricht

Other trials in Netherlands

About this study

Official title: 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.

Conditions
Obesity, Diabetes
Being tested
adipose tissue sampling
Medical subject headings
Obesity, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adipose tissue samplingOther

    adipose tissue (subcutaneous and visceral adipose tissue) sampling during abdominal surgery and phenotype determination

Study groups in NCT02598544
Study groupRoleWhat they receive
lean menOtherNot described
Receives: Other: adipose tissue sampling
Obese men without type 2 diabetesOtherNot described
Receives: Other: adipose tissue sampling
Obese men with type 2 diabetesOtherNot described
Receives: Other: adipose tissue sampling

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Glycerol release by mature adipocytes, isolated from subcutaneous and visceral adipose tissue, upon stimulation with isoprenalin or ANP (ex vivo)

    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

    Measured: day 1

  2. ANP receptor expression profiles on mRNA and protein level in both adipose tissue depots for both lean and obese subjects.

    Receptor expression determination in order to clarify the underlying mechanism responsible for possible differences in lipolytic responses.

    Measured: day 1

  3. Adipose tissue inflammation

    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.

    Measured: day 1

Secondary outcomes (14)

  1. Body composition

    Body composition (body fath percentage), measured by BIA

    Measured: day 1

  2. BMI (kg/m²)

    Measured: day 1

  3. body height (m)

    Measured: day 1

  4. weight (kg)

    Measured: day 1

  5. hip circumference (cm)

    Measured: Day 1

  6. waist (cm)

    Measured: Day 1

  7. blood glucose

    Measured: day 1

  8. blood insuline

    Measured: day 1

  9. blood FFA

    Measured: day 1

  10. blood triglycerides

    Measured: day 1

  11. blood glycated hemoglobin

    Measured: day 1

  12. blood ANP

    fasting blood sample to determine blood glucose, insulin, FFA, , glycated hemoglobin and ANP

    Measured: day 1

  13. blood pressure (mmHg)

    Measured: Day 1

  14. Concomitant medication

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2015 (estimated)
  2. Study startMay 2013
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02598544
Sponsor's protocol ID
14.17/REVA14.02
Acronym
ERLO
Status last verified
Nov 2016
First submitted
16 Oct 2015
Last updated
18 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing adipose tissue sampling in people with Obesity and Diabetes, run by Hasselt University at 4 sites in 2 countries.

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 1 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 4 sites in Belgium, Netherlands. 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?

Glycerol release by mature adipocytes, isolated from subcutaneous and visceral adipose tissue, upon stimulation with isoprenalin or ANP (ex vivo) (time frame: day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02598544.

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.

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