NCT06907212

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 2, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.2 years

First QC Date

December 16, 2024

Last Update Submit

March 31, 2025

Conditions

Keywords

Human primary adipocytesObesitySystems-wide biologyGene regulatory networks

Outcome Measures

Primary Outcomes (2)

  • Adipocytes specific signaling

    RNA sequencing of isolated adipocytes

    June 2024 - Sept 2025

  • Gene regulatory networks

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

    June 2024 - Sept 2025

Secondary Outcomes (3)

  • Adipocyte cell size

    Sept 2024 - Dec 2024

  • Standard blood tests

    Jan 2025 - Sept 2025

  • Adipokine secretion

    Jan 2025 - Sept 2025

Study Arms (1)

Male and female participants with various BMI

Both male and female participants will be included, with the goal of creating a cohort in which all levels of BMI are equally present. Adipocytes of the abdominal subcutaneous and visceral adipose tissue depots will be isolated and sequenced to perform linear regression analysis of transcriptional networks across BMI.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Recruitment of subjects will be from patients referred for surgical cholecystectomies, herniotomies or similar operations, at Bispebjerg Hospital.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg hospital

Copenhagen, 2400, Denmark

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Isolated adipocytes of human adipose tissue

MeSH Terms

Conditions

Obesity, AbdominalObesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Susanne Mandrup, PhD

    s.mandrup@bmb.sdu.dk

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

April 2, 2025

Study Start

April 1, 2023

Primary Completion

June 1, 2025

Study Completion

September 1, 2025

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations