Effect of Obesity on Extracellular Matrix Composition

NCT06304506 | Recruiting

• 1 other identifier: 514-0894/23-3000
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Adipose Tissue

Keywords

Extracellular matrix compostion; Obesity; Age

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Young obese men

EXPERIMENTAL

BMI \[30, 40\] Age \[18, 35\]

Other: Cross sectional study

Young healthy men

EXPERIMENTAL

BMI \[20, 25\] Age \[18, 35\]

Other: Cross sectional study

Old healthy men

EXPERIMENTAL

BMI \[20, 25\] Age \[60, 75\]

Other: Cross sectional study

Interventions

Cross sectional study OTHER

Physiological testing, Sampling of blood and abdominal adipose tissue and respiratory measurements at rest and during exercise

Old healthy men; Young healthy men; Young obese men

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[20,25\]

You may not qualify if:

• Present or former cardiovascular disease and chronical inflammatory disease
• Consumption of medications and supplements that influence substrate use at rest and/or during exercise

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Xlab, Faculty of Health and Medical Sciences, University of Copenhagen

Copenhagen, 2200, Denmark

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Cross-Sectional Studies

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jørn W Helge, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jørn Wulff W Helge, PhD

CONTACT

+4528757506; jhelge@sund.ku.dk

Christoffer Clemmensen, PhD

CONTACT

+4522916363; chc@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cross sectional study with three groups

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion: November 15, 2024
• Study Completion: December 30, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: The data will be available after publication and indefinately
• Access Criteria: Not known at this state

Locations

DK (1)