Clinical trial NCT06304506: Effect of Obesity on Extracellular Matrix Composition
Official title: Effect of Obesity on Extracellular Matrix Composition in Healthy Males With Normal and High BMI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adipose Tissue
Keywords: Extracellular matrix compostion
Obesity
Age
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross sectional study with three groups
Primary purpose: BASIC_SCIENCE

Brief 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The effect of obesity and age on adipose tissue extracellular matrix composition
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Jørn W Helge, PhD
role: PRINCIPAL_INVESTIGATOR
References: