Ignite Creation Date:
2024-05-06 @ 7:48 PM
Last Modification Date:
2024-10-26 @ 3:14 PM
Study NCT ID:
NCT06145126
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2023-10-09
Brief Title:
Effects of Glucocortioids in Human Skeletal Muscle Adipose Tissue and Skin
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Effects of Glucocortioids in Human Skeletal Muscle Adipose Tissue and Skin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-10
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:
FUSION
Brief Summary:
BACKGROUND A notorious and dreaded adverse effect of glucocorticoids GC is redistribution of muscle and fat mass towards muscle wasting and visceral obesity Fibroadipogenic progenitors FAPs are hypothesized to mediate this process
AIM Utilizing human data the investigators study the effects of GC exposure on skeletal muscle structure and function adipose tissue and skin in healthy older subjects
METHODS FAPs will be analyzed in biopsies from skeletal muscles adipose tissue and skin and further characterized using scRNA-sequencing and Fluorescence-Activated Cell Sorting Body composition including muscle mass DXA scan muscle strength spontaneous physical activity and glucose homeostasis are recorded
PERSPECTIVES The investigators combine translational research with multidisciplinary and international collaboration to elucidate the pathophysiology of GC excess which is of significant clinical interest since 3 of the Danish population receive GC treatment
AIM Utilizing human data the investigators study the effects of GC exposure on skeletal muscle structure and function adipose tissue and skin in healthy older subjects
METHODS FAPs will be analyzed in biopsies from skeletal muscles adipose tissue and skin and further characterized using scRNA-sequencing and Fluorescence-Activated Cell Sorting Body composition including muscle mass DXA scan muscle strength spontaneous physical activity and glucose homeostasis are recorded
PERSPECTIVES The investigators combine translational research with multidisciplinary and international collaboration to elucidate the pathophysiology of GC excess which is of significant clinical interest since 3 of the Danish population receive GC treatment
Detailed Description:
Design randomized double blind placebo-controlled trial The aim is to study the effect of short-term GC exposure on skeletal muscle skin adipose tissue in 12 healthy adults above the age of 50 years This age group is close to that of patients receiving short-term high dose anti-inflammatory prednisolone treatment and thus provides a bridge between a clinically observered problem The participants will be randomized to receive either prednisolone 375mgd or placebo treatment for five consecutive days In addition to muscle skin and adipose tissue biopsies and body composition measurement DXA each participant will undergo the following measurements before and after the intervention spontaneous physical activity actigraphy ambulatory 24-hour blood pressure continuous glucose monitoring CGM pulse wave velocity PWV and muscle strength Each participant is studied before and after the 5-day treatment period
Outcomes
FAPs expression in skeletal muscle and adipose tissue
Fluorescence Activated Cell Sorting FACS mediated quantification isolation and transcriptomic profiling at population and single-cell level of FAPs and immunological cells
Time-to-first division of isolation FAPs
In vitro fibro- and adipogenic differentiation of FAPs
Single cell transcriptome analysis scRNA-seq to profile cell types in a hypothesis-generating perspective
Functional outcomes Muscle mass and strength DXA scan and isometric quadriceps strength and spontaneous physical activity actigraphy
Metabolic outcomes circadian blood glucose and blood pressure and basal insulin sensitivity
Outcomes
FAPs expression in skeletal muscle and adipose tissue
Fluorescence Activated Cell Sorting FACS mediated quantification isolation and transcriptomic profiling at population and single-cell level of FAPs and immunological cells
Time-to-first division of isolation FAPs
In vitro fibro- and adipogenic differentiation of FAPs
Single cell transcriptome analysis scRNA-seq to profile cell types in a hypothesis-generating perspective
Functional outcomes Muscle mass and strength DXA scan and isometric quadriceps strength and spontaneous physical activity actigraphy
Metabolic outcomes circadian blood glucose and blood pressure and basal insulin sensitivity
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