Effects of Glucocortioids in Human Skeletal Muscle, Adipose Tissue and Skin

NCT06145126 | Unknown DMC

• 1 other identifier: FUSION
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glucocorticoids Toxicity; Iatrogenic Effect

Outcome Measures

Primary Outcomes (1)

• FAPs expression in skeletal muscle, adipose tissue, and skin

  Single cell transcriptome analysis (scRNA-seq) to profile cell types in a hypothesis-generating perspective.

  2 Years

Secondary Outcomes (6)

• Dual X-ray scan (DXA)

  2 Years

• Metabolic outcomes - Circadian blood glucose

  Years

• Dynamometer

  2 Years

• 24h blood pressure

  2 Years

• Basal insulin sensitivity.

  2 Years

Study Arms (2)

Start pred/End placebo

OTHER

Both arms will receive both placebo and prednisone

Other: Prednisolone; Other: Placebo

Start placebo/End pred

OTHER

Both arms will receive both placebo and prednisone

Other: Prednisolone; Other: Placebo

Interventions

Prednisolone OTHER

Predisolone is used as a tool to elicit a physiological response (toolbox trial) and not as a pharmaceutical agent/treatment.

Start placebo/End pred; Start pred/End placebo

Placebo OTHER

Placebo to predinisolon

Start placebo/End pred; Start pred/End placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written and oral consent prior to study beginning
• Age of or above 50 years
• Healthy (uncomplicated hypertension and hypercholesteroleamia is accepted)
• BMI of or below 35

You may not qualify if:

• Consumption of glucocorticoid pharmaceuticals (inhalation steroids, intra-articular or intra-muscular injections, steroid creme group IV-V used in the genital area). Allowed pharmaceuticals: ocular drops, nasal sprays/drops, steroid creme group I-III, steroid creme group IV-V used in non-genital areas
• Alcohol consumption of more than 21 units per week
• Consumption of strong CYP3A4 inhibitors/inducers
• Serious comorbidity (heart, liver, or kidney failure, as well as cooncurrent cancer/chemotherapy treatment)
• High daily activity level (more than 30min per day or more than 2 organized workouts per week)

Sponsors & Collaborators

• University of Aarhus: lead

MeSH Terms

Interventions

Prednisolone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Placebo-controlled, randomized, crossover

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 22, 2023
• Study Start: December 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: July 1, 2025
• Last Updated: November 22, 2023

Record last verified: 2023-10