Clinical trial NCT02598544: Endocrine Regulation of Lipolysis in Obesity and Diabetes
Official title: Atrial Natriuretic Peptide (ANP)-Induced Lipid Mobilization Regulation in Different Adipose Tissue Depots of Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Diabetes
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Jessa Hospital
First posted: 2015-11-06
Enrollment: 55
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Glycerol release by mature adipocytes, isolated from subcutaneous and visceral adipose tissue, upon stimulation with isoprenalin or ANP (ex vivo)
timeFrame: day 1
measure: ANP receptor expression profiles on mRNA and protein level in both adipose tissue depots for both lean and obese subjects.
timeFrame: day 1
measure: Adipose tissue inflammation
timeFrame: day 1
Secondary outcomes:
measure: Body composition
timeFrame: day 1
measure: BMI (kg/m²)
timeFrame: day 1
measure: body height (m)
timeFrame: day 1
measure: weight (kg)
timeFrame: day 1
measure: hip circumference (cm)
timeFrame: Day 1
measure: waist (cm)
timeFrame: Day 1
measure: blood glucose
timeFrame: day 1
measure: blood insuline
timeFrame: day 1
measure: blood FFA
timeFrame: day 1
measure: blood triglycerides
timeFrame: day 1
measure: blood glycated hemoglobin
timeFrame: day 1
measure: blood ANP
timeFrame: day 1
measure: blood pressure (mmHg)
timeFrame: Day 1
measure: Concomitant medication
timeFrame: Day 1
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
affiliation: Hasselt University
name: Dominique Hansen, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Maastricht University
name: Ellen Blaak, prof. dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Kenneth Verboven, drs.
role: STUDY_CHAIR
References: