Deciphering a Novel and Unique Brown Adipose Tissue Depot in Women

NCT06426082 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-05-23

No results posted yet for this study

Summary

Type of Study: Clinical Trial

Goal: The goal of this clinical trial is to investigate specific brown and beige fat cells in the dorsocervical area of young, lean adult women.

Participant Population/Health Conditions: The study will involve 40 young, lean adult women.

Main Questions: The main questions this study aims to answer are:

* Are there active brown or beige adipocytes in the subcutaneous fat of the dorsocervical area (i.e., iBAT)?
* What is the secretory function of these adipocytes?
* How do traditional interventions like cold exposure, as well as new approaches like Beta-2 agonist stimulation and exercise, affect the thermogenesis of these fat cells at the cellular and molecular levels?

Participants Will:

Be randomized into one of four groups: thermoneutral exposure, cold exposure, aerobic exercise, or Beta-2 agonist treatment.

Follow their assigned regimen for 4 weeks. Provide tissue samples from the dorsocervical area and abdomen before and after the 4-week intervention.

Undergo analysis of these samples using advanced techniques to understand the presence and activity of brown and beige fat cells.

Comparison Group: Researchers will compare the effects of different interventions (thermoneutral exposure, cold exposure, aerobic exercise, Beta-2 agonist treatment) on the presence and thermogenesis of brown and beige fat cells in the dorsocervical area.

Conditions

  • Cardiometabolic Diseases

Interventions

BEHAVIORAL

Thermoneutral condition

Participants will be exposed 2 hours/day at 32ºC for 5 days/week

BEHAVIORAL

Cold condition

Participants will be exposed 2 hours/day at 18ºC for 5 days/week

BEHAVIORAL

Aerobic exercise condition

Participants will perform aerobic exercise training 5 days/week at 65% heart rate reserve for 60 minutes each training session

DRUG

Salbutamol

Participants will take salbutamol 12 mg/day. 7 days week

Sponsors & Collaborators

  • Leiden University Medical Center

    collaborator OTHER
  • ETH Zurich (Switzerland)

    collaborator OTHER
  • Universidad de Almeria

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2025-08-31
Completion
2026-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06426082 on ClinicalTrials.gov