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临床试验/NCT06304506
NCT06304506招募中不适用

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

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
The effect of obesity and age on adipose tissue extracellular matrix composition

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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]

排除标准

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

研究组 & 干预措施

Young obese men

Experimental

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

干预措施: Cross sectional study (Other)

Young healthy men

Experimental

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

干预措施: Cross sectional study (Other)

Old healthy men

Experimental

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

干预措施: Cross sectional study (Other)

结局指标

主要结局

The effect of obesity and age on adipose tissue extracellular matrix composition

时间窗: 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.

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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jørn Wulff Helge

Professor

University of Copenhagen

研究点 (2)

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