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OpenTrials
Enrolling by Invitation

NCT Number: NCT06907212

Transcriptional Changes in Isolated Human Adipocytes During Obesity

Adipocytes play an important role in our body through their function as metabolic energy stores in the form of fat deposits, which are stored when metabolic energy is in excess and released when energy levels are low. In severe obesity, adipose tissue grows through the production of more adipocytes from stem cells (hyperplasia) and the increase in the size of existing adipocytes (hypertrophy). This ability of adipocytes, to maintain their functionality during tissue expansion, is critical in determining the development of obesity-related comorbidities. However, not all adipocytes are the same as adipocyte function differs greatly depending on the depot in which they are found. To elucidate the mechanisms underlying adipocyte adaptability, it is necessary to obtain a deep systems biology understanding of how signaling in different types of adipocytes regulates metabolism and function. Currently, this research group is conducting a systems biology analysis of adipocyte plasticity in obesity in mouse models, but adipose tissue biopsies from different depots in humans are lacking and needed to investigate the regulation of adipocyte function and plasticity in humans. Such studies of adipocytes are crucial for the understanding how obesity affects adipose tissue function and leads to comorbidities.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bispebjerg hospital

Copenhagen, 2400, Denmark

About this study

The development of overweight and obesity is associated with major changes in adipose tissue, including structural changes in cell type composition as well as gene expression in individual adipose tissue cell types. The molecular mechanisms underlying these changes are not yet known. The investigators therefore hypothesized that overweight and obesity cause changes in the transcriptional program of adipocytes and this leads to impaired function of adipocytes. This study will use advanced genomic technologies available that can measure the dynamic changes in the transcriptome and genomic landscape of isolated adipocytes from patient biopsies, to better understand which changes in the adipocytes in particular underlie the severe comorbidities that occur with the development of obesity. It is expected that the described project will contribute important knowledge about adipocyte-specific transcriptional programs that play a crucial role in obesity. This and thus may contribute to the knowledge required to develop adapted- and personalized medicines, or new therapeutic approaches to treat obesity and its associated diseases.

Recruitment of 100 subjects will be from patients referred for surgical cholecystectomies, herniotomies or similar operations at Bispebjerg Hospital. The control group will consist of study participants with a BMI ≥ 19 kg/m2 and < 25 kg/m2, and the "case" group will consist of study participants with a BMI ≥ 25 kg/m2. When including subjects, emphasis will be placed on achieving a control group of approximately 25 subjects and a "case" group of approximately 75 subjects with varying degrees of elevated BMI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years old
  • BMI> 19 kg/m2
  • Can receive oral and written information and give appropriate consent

Exclusion criteria

  • Active viral hepatitis, HIV positive
  • Autoimmune diseases (i.e. lupus)
  • Chronic use of corticosteroids (cortisone)
  • Unable to give appropriate consent
  • Contraindications for biopsy: bleeding tendency.
  • Cancer or other comorbidity with an expected survival time of less than 12 months

Treatment and study plan

Primary outcomes

  1. Adipocytes specific signaling

    Time frame: June 2024 - Sept 2025

    RNA sequencing of isolated adipocytes

  2. Gene regulatory networks

    Time frame: June 2024 - Sept 2025

    ATAC sequencing of isolated adipocytes to determine the accessible chromatin regions.

Secondary outcomes

  1. Adipocyte cell size

    Time frame: Sept 2024 - Dec 2024

    Determining the average adipocyte cell size and cell size distribution in both tissue depots.

  2. Standard blood tests

    Time frame: Jan 2025 - Sept 2025

    Analysis of standard blood tests by research diagnostics department of the hospital; including nutritional status (haemoglobin, magnesium, zinc, phosphate, ferritin, iron, albumin. Vitamin D, urea), coagulation (INR, APTT, platelets), blood lipids (total cholesterol, LDL, HDL, triglycerides) and insulin resistance (HOMA-IR, HbA1c, C-peptide, glucose).

  3. Adipokine secretion

    Time frame: Jan 2025 - Sept 2025

    Storage of extra serum and plasma for additional analysis of adipokines such as Adiponectin and Leptin.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • Bispebjerg Hospital

Registry information

Official study title

Human Adipocytes - Transcriptional Network Changes Associated With Obesity

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 2, 2025
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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