Effect of Obesity on Extracellular Matrix Composition

NCT ID: NCT06304506

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2024-12-30

Brief Summary

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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

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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.

Conditions

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Adipose Tissue

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Cross sectional study with three groups
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Young obese men

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

Group Type EXPERIMENTAL

Cross sectional study

Intervention Type OTHER

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

Young healthy men

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

Group Type EXPERIMENTAL

Cross sectional study

Intervention Type OTHER

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

Old healthy men

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

Group Type EXPERIMENTAL

Cross sectional study

Intervention Type OTHER

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

Interventions

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Cross sectional study

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Jørn Wulff Helge

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jørn W Helge, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Jørn Wulff W Helge, PhD

Role: CONTACT

+4528757506

Christoffer Clemmensen, PhD

Role: CONTACT

+4522916363

Facility Contacts

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Jørn M Helge, PhD

Role: primary

+4528757506

Other Identifiers

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514-0894/23-3000

Identifier Type: -

Identifier Source: org_study_id

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