Effect of Obesity on Extracellular Matrix Composition

Adipose Tissue Clinical Trial

— EOBECM  

Official title:

Effect of Obesity on Extracellular Matrix Composition in Healthy Males With Normal and High BMI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06304506
• Other study ID #: 514-0894/23-3000
• Status: Recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2024
• Source: University of Copenhagen
• Contact: Jørn Wulff W Helge, PhD
• Phone: +4528757506
• Email: jhelge[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The experiment is a simple cross-sectional study with three groups (n=10) in each group, young and old healthy men and obese young men. The study will investigate the composition of the adipose tissue extra cellular matrix.

The main questions to answer,

• is there differences in the adipose tissue extracellular matrix in obese compared to young men is there differences in the adipose tissue extracellular matrix in old compared to young men

Description:

Three groups of young (n=10) and old (n=10) healthy men and obese young (n=10) men are recruited.

After verbal and written information is provided signed consent is obtained.

Subjects arrive at the lab overnight fasted and not having done exercise the prior day and having consumed a normal isocaloric carbohydrate rich diet.

After a voiding and a 15 min rest body composition is determined by DXA. After this blood pressure is measured in the supine position in triplicate separated by 1 min. Following this a venous blood sample is obtained from a cubital vein, and kept on ice until further handling.

Subsequently an adipose tissue biopsy is obtained by the Bergström technique applied with suction from an incision 3-5 cm lateral from the umbilicus. After compression and a 30 min rest, the subject perform an incremental exercise test to determine maximal fat oxidation. In brief pulmonary oxygen uptake and carbon dioxide excretion is measured using a COSMED Quark B2 on-line system during 5 min rest sitting on a cycle ergometer, and then during exercise with 3 min increments starting at 60 Watt and increasing by 35 watts. When the respiratory exchange ratio is above 1 the exercise is stopped. After a 5 min break an incremental test until voluntary exhaustion is performed to determine maximal oxygen uptake. This completes the experiment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 30, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Healthy men aged [18,35] and BMI [20,25]

• Obese men aged [18,35] and BMI [30,40]

• Healthy older men aged [60,75] and BMI [20,25]

Exclusion Criteria:

• Present or former cardiovascular disease and chronical inflammatory disease

• Consumption of medications and supplements that influence substrate use at rest and/or during exercise

Related Conditions & MeSH terms

• Adipose Tissue
• Obesity

Intervention

Other:
• Cross sectional study
Physiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise

Locations

Country	Name	City	State
Denmark	Xlab, Faculty of Health and Medical Sciences, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of obesity and age on adipose tissue extracellular matrix composition	Adipose tissue extracellular matrix composition will be measured in abdominal subcutaneous adipose tissue sampled 3-5 cm lateral to the umbilicus in 30 male subjects; hereof 10 young, 10 old and 10 young and obese.; In brief the tissue will be delipidated and subsequently separated by DEAE chromotography (A weak anion exchange) and subsequently analysis of glycosaminoglycan disaccharide composition will be performed by MS.	The human experimental days will be done over the first 6 months of 2024. After informed consent is obtained, each participant will be tested on one day. The laboratory tissue analysis will be performed second half of 2024.