Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06426082
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-23
First Post:
2023-10-11
Brief Title:
Deciphering a Novel and Unique Brown Adipose Tissue Depot in Women
Sponsor:
Universidad de Almeria
Organization:
Universidad de Almeria
Study Overview
Official Title:
Deciphering the Molecular and Secretory Functions of a Novel and Unique Brown Adipose Tissue Depot in Women
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DEBATE
Brief 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 PopulationHealth 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 ie 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
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 PopulationHealth 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 ie 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
Detailed Description:
Cardiometabolic diseases affect almost 50 of the population in the Western World While lifestyle plus pharmacological interventions may provide short-term benefits more research is needed to understand the long-term effectiveness and underlying molecular mechanisms Brown adipose tissue BAT is a thermogenic tissue that combusts large amounts of glucose and lipids to generate heat and secretes signalling molecules known as batokines that can influence cardiometabolic health Previous research has shown that BAT is active in adults primarily in the supraclavicular region as demonstrated by the uptake of 18F-Fluorodeoxyglucose Recently it has been demonstrated that a rare subpopulation of brown adipocytes increases their abundance at higher temperatures and can regulate the thermogenesis of neighbouring adipocytes Thus it is plausible that classical eg cold exposure and novel interventions ie Beta-2 stimulation and exercise that can activate BAT would induce a remodelling in the brownbeige subpopulation adipocytes that govern whole tissue thermogenesis These unstudied changes in human BAT physiology could potentially explain how BAT activation could enhance cardiometabolic health However despite over a decade of research our understanding of the role of BAT in human physiology in humans is limited This lack of knowledge may be mainly explained because i obtaining biological samples of human BAT is very difficult and ii the seasonal variation strongly influences the current gold standard PET-CT scan Given the pilot data found in this proposal young lean adult women may have a novel and undescribed thermogenic active BAT depot at the dorsocervical area ie interscapular BATiBAT
Based on that the main hypothesis is that there are brown andor beige adipocytes present within the subcutaneous adipose tissue of the dorsocervical area ie iBAT that have a unique composition of adipocyte subpopulations and specific secretory functions Additionally the specific subpopulations of brown andor beige adipocytes related to thermogenesis in iBAT can be increased through exposure to cold temperatures Beta-2 agonist stimulation and exercise in young lean women
Thus the main objective of this study is to investigate whether the subcutaneous fat in the dorsocervical area contains active brown andor beige adipocytes ie iBAT understand its secretory function and study the impact of traditional eg cold exposure and new interventions eg Beta-2 agonist and exercise on iBAT thermogenesis at the cellular and molecular levels
Thus the DEBATE project will carry out a randomized controlled trial where 40 young lean adult women will be randomized into a thermoneutral exposure group 2 hoursday at 32ºC 5 daysweek or a cold exposure group 2 hoursday at 18ºC 5 daysweek or an aerobic exercise group 5 daysweek at 65 heart rate reserve for 60 minutes or a Beta-2 agonist group salbutamol 12 mgday 7 days week Before and after the 4-week intervention iBAT tissue samples from the dorsocervical area and subcutaneous white adipose tissue scWAT from the abdomen will be collected In these biological samples the investigators will apply a set of cutting-edge omics eg single nucleus RNA-seq that will allow us to investigate whether iBAT is present and metabolically active in adults The investigators will also conduct a set of in vitro experiments to discover the secretory function of this novel depot
Based on that the main hypothesis is that there are brown andor beige adipocytes present within the subcutaneous adipose tissue of the dorsocervical area ie iBAT that have a unique composition of adipocyte subpopulations and specific secretory functions Additionally the specific subpopulations of brown andor beige adipocytes related to thermogenesis in iBAT can be increased through exposure to cold temperatures Beta-2 agonist stimulation and exercise in young lean women
Thus the main objective of this study is to investigate whether the subcutaneous fat in the dorsocervical area contains active brown andor beige adipocytes ie iBAT understand its secretory function and study the impact of traditional eg cold exposure and new interventions eg Beta-2 agonist and exercise on iBAT thermogenesis at the cellular and molecular levels
Thus the DEBATE project will carry out a randomized controlled trial where 40 young lean adult women will be randomized into a thermoneutral exposure group 2 hoursday at 32ºC 5 daysweek or a cold exposure group 2 hoursday at 18ºC 5 daysweek or an aerobic exercise group 5 daysweek at 65 heart rate reserve for 60 minutes or a Beta-2 agonist group salbutamol 12 mgday 7 days week Before and after the 4-week intervention iBAT tissue samples from the dorsocervical area and subcutaneous white adipose tissue scWAT from the abdomen will be collected In these biological samples the investigators will apply a set of cutting-edge omics eg single nucleus RNA-seq that will allow us to investigate whether iBAT is present and metabolically active in adults The investigators will also conduct a set of in vitro experiments to discover the secretory function of this novel depot
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None