Effect of Obesity on Extracellular Matrix Composition (EOBECM)

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

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

Study Overview

• Status: Recruiting
• Conditions: Adipose Tissue
• Intervention / Treatment: Other: Cross sectional study

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jørn Wulff W Helge, PhD; Phone Number: +4528757506; Email: jhelge@sund.ku.dk
• Study Contact Backup: Name: Christoffer Clemmensen, PhD; Phone Number: +4522916363; Email: chc@sund.ku.dk

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Recruiting
    • Xlab, Faculty of Health and Medical Sciences, University of Copenhagen
    • Contact: Jørn M Helge, PhD; Phone Number: +4528757506; Email: jhelge@sund.ku.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Young obese men; BMI [30, 40] Age [18, 35]	Other: Cross sectional study; Physiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise
Experimental: Young healthy men; BMI [20, 25] Age [18, 35]	Other: Cross sectional study; Physiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise
Experimental: Old healthy men; BMI [20, 25] Age [60, 75]	Other: Cross sectional study; Physiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Investigators: Principal Investigator: Jørn W Helge, PhD, University of Copenhagen

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): November 15, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Obesity; Age; Extracellular matrix compostion
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 514-0894/23-3000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When the experiments are concluded and the paper(s) are accepted that data will be able upon reasonable request
• IPD Sharing Time Frame: The data will be available after publication and indefinately
• IPD Sharing Access Criteria: Not known at this state
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No