Endocrine Regulation of Lipolysis in Obesity and Diabetes

Obesity Clinical Trial

— ERLO  

Official title:

Atrial Natriuretic Peptide (ANP)-Induced Lipid Mobilization Regulation in Different Adipose Tissue Depots of Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02598544
• Other study ID #: 14.17/REVA14.02
• Status: Completed
• Phase: N/A
• First received: October 16, 2015
• Last updated: November 16, 2016
• Start date: May 2013
• Est. completion date: April 2015

Study information

• Verified date: November 2016
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes
• Obesity

Intervention

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

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek
Belgium	Ziekenhuis Oost-Limburg	Genk
Belgium	Jessa Ziekenhuis	Hasselt
Netherlands	Maastricht University	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	day 1	No
Primary	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.	day 1	No
Primary	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.	day 1	No
Secondary	Body composition	Body composition (body fath percentage), measured by BIA	day 1	No
Secondary	BMI (kg/m²)		day 1	No
Secondary	body height (m)		day 1	No
Secondary	weight (kg)		day 1	No
Secondary	hip circumference (cm)		Day 1	No
Secondary	waist (cm)		Day 1	No
Secondary	blood glucose		day 1	No
Secondary	blood insuline		day 1	No
Secondary	blood FFA		day 1	No
Secondary	blood triglycerides		day 1	No
Secondary	blood glycated hemoglobin		day 1	No
Secondary	blood ANP	fasting blood sample to determine blood glucose, insulin, FFA, , glycated hemoglobin and ANP	day 1	No
Secondary	blood pressure (mmHg)		Day 1	No
Secondary	Concomitant medication		Day 1	No